X-static Silverseal Hydrogel Dressing 4 X 5: Package Insert and Label Information

X-STATIC SILVERSEAL HYDROGEL DRESSING 4 X 5-
X-STATIC SILVERSEAL HYDROGEL DRESSING 2 X 3-
X-STATIC SILVERSEAL HYDROGEL DRESSING 2 X 2-
X-STATIC SILVERSEAL HYDROGEL DRESSING 3-
HYDRESS-
Alliqua Inc

Apply as a single layer.

Overlay with conventional dressings.

SilverSeal ® Hydrogel Dressing is intended for the management of wounds and to provide an antimicrobial barrier

Silverseal® Hydrogel is intended for the management of wounds and to provide an antimicrobial barrier

Applicable to:

Partial and full thickness ulcers, leg ulcers (vascular, venous, pressure and diabetic), superficial wounds, abrasions, first and second degree burns, and donor sites.
Silverseal® Hydrogel Dressing contains approximately 1.5% X-Static® silver coated fiber

Antibacterial activity was confirmed via in vitro studies of bacterial growth dressing.

To facilitate removal, moisten with sterile water.

Caution: federal law restricts this device to sale by or on the order at a licensed practitioner.

Use before expiration date.

Principal Display Panel – 2” X 2” Dressing Box Label

SILVER
SEAL®

(00)00000000000000
HYDROGEL DRESSING
NDC 58198-122-10 PRODUCT CODE
AA-000000-000
STERILE Contents: Ten (10) Dressing
SINGLE USE ONLY 2” X 2” (5.1cm X 5.1cm)

Manufactured by Aquamed Technologies Inc.
For Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047www.Alliqua.com

Principal Display Panel – 2” X 2” Dressing Box Label
(click image for full-size original)

Principal Display Panel – 2” X 2” Dressing Pouch Label

SILVER
SEAL®

(00)00000000000000
HYDROGEL DRESSING
NDC 58198-122-01 PRODUCT CODE
AA-000000-000
STERILE Contents: One (1) Dressing
SINGLE USE ONLY 2” X 2” (5.1cm X 5.1cm)

Manufactured by Aquamed Technologies Inc.
For Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047www.Alliqua.com

Principal Display Panel – 2” X 2” Dressing Pouch Label
(click image for full-size original)

Principal Display Panel – 2” X 3” Dressing Box Label

NDC 58198-123-10

SILVER
SEAL®

(01)10816789010027

HYDROGEL DRESSING

PRODUCT CODE
AB-200300-103


STERILE Contents: Ten (10) dressings
SINGLE USE ONLY 2” X 3” (5.1cm X 7.6cm)

Manufactured by Aquamed Technologies Inc.

for Alliqua Biomedical Inc.2150 Cabot Boulevard West, Langhorne, PA 19047

www.Alliqua.com

Principal Display Panel – 2” X 3” Dressing Box Label
(click image for full-size original)

Principal Display Panel – 4” X 5” Dressing Box Label

NDC 58198-123-01

SILVER
SEAL®

(01)00816789010020 HYDROGEL DRESSING

PRODUCT CODE
AB-200300-103

STERILE Contents: One (1) dressing
SINGLE USE ONLY 2” X 3” (5.1cm X 7.6cm)

Manufactured by Aquamed Technologies Inc.

for Alliqua Biomedical Inc.2150 Cabot Boulevard West, Langhorne, PA 19047

Principal Display Panel – 4” X 5” Dressing Box Label
(click image for full-size original)

Principal Display Panel – 3” Circle Dressing Box Label

SILVER
SEAL®

(00)00000000000000
HYDROGEL DRESSING
NDC 58198-130-10 PRODUCT CODE
AA-000000-000
STERILE Contents: Ten (10) Dressing
SINGLE USE ONLY 3” Circle (7.6cm circle)

Manufactured by Aquamed Technologies Inc.
For Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047www.Alliqua.com

Principal Display Panel – 3” Circle Dressing Box Label
(click image for full-size original)

Principal Display Panel – 3” Circle Dressing Pouch Label

SILVER
SEAL®

(00)00000000000000
HYDROGEL DRESSING
NDC 58198-130-01 PRODUCT CODE
AA-000000-000
STERILE Contents: One (1) Dressing
SINGLE USE ONLY 3” Circle (7.6cm circle)

Manufactured by Aquamed Technologies Inc.
For Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047www.Alliqua.com

Principal Display Panel – 3” Circle Dressing Pouch Label
(click image for full-size original)

Principal Display Panel – 4” X 4″ Circle Dressing Box Label

NDC 58198-044-10 PRODUCT CODE

AB-400400-001

HYDRESSTM

(01)10816789010003

HYDROGEL DRESSING
STERILE Contents: Ten (10) Hydrogel Dressings
SINGLE USE ONLY 4” X 4” (10cm X 10cm)

Manufactured by Aquamed Technologies Inc. for Alliqua Biomedical Inc.2150 Cabot Boulevard West, Langhorne, PA 19047 | Tel 855-425-5478 | www.Alliqua.com

Principal Display Panel – 4” X 4" Circle Dressing Box Label
(click image for full-size original)

Principal Display Panel – 4” X 4″ Circle Dressing Pouch Label

NDC 58198-044-10 PRODUCT CODE

AB-400400-001

HYDRESSTM

(01)00816789010006

HYDROGEL DRESSING
STERILE Contents: One (1) dressing
SINGLE USE ONLY 4” X 4” (10cm X 10cm)

Manufactured by Aquamed Technologies Inc. for Alliqua Biomedical Inc.2150 Cabot Boulevard West, Langhorne, PA 19047 | Tel 855-425-5478 | www.Alliqua.com

Principal Display Panel – 4” X 4" Circle Dressing Pouch Label
(click image for full-size original)

Principal Display Panel – 4” X 5” Dressing Box Label

NDC 58198-145-10

SILVER
SEAL®

PRODUCT CODE
AB-400500-105

(01)10816789010010

HYDROGEL DRESSING
STERILE Contents: Ten (10) dressings
SINGLE USE ONLY 4” X 5” (10cm X 12.7cm)

Manufactured by Aquamed Technologies Inc. for Alliqua Biomedical Inc.2150 Cabot Boulevard West, Langhorne, PA 19047 | www.Alliqua.com

Principal Display Panel – 4” X 5” Dressing Box Label
(click image for full-size original)

Principal Display Panel – 4” X 5” Dressing Box Label

NDC 58198-145-01

SILVER
SEAL®

PRODUCT CODE
AB-400500-105

(01)00816789010013

HYDROGEL DRESSING
STERILE Contents: One (1) dressing
SINGLE USE ONLY 4” X 5” (10cm X 12.7cm)

Manufactured by Aquamed Technologies Inc. for Alliqua Biomedical Inc.2150 Cabot Boulevard West, Langhorne, PA 19047 | www.Alliqua.com

Principal Display Panel – 4” X 5” Dressing Box Label
(click image for full-size original)
X-STATIC SILVERSEAL HYDROGEL DRESSING 4 X 5
Product Information
Product Type Item Code (Source) NHRIC:58189-145
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:58189-145-10 10 POUCH in 1 CARTON contains a POUCH (58189-145-01)
1 NHRIC:58189-145-01 1 in 1 POUCH This package is contained within the CARTON (58189-145-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Premarket Notification K040019 05/15/2013
X-STATIC SILVERSEAL HYDROGEL DRESSING 2 X 3
Product Information
Product Type Item Code (Source) NHRIC:58189-123
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:58189-123-10 10 POUCH in 1 CARTON contains a POUCH (58189-123-01)
1 NHRIC:58189-123-01 1 in 1 POUCH This package is contained within the CARTON (58189-123-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Premarket Notification K040019 05/15/2013
X-STATIC SILVERSEAL HYDROGEL DRESSING 2 X 2
Product Information
Product Type Item Code (Source) NHRIC:58189-122
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:58189-122-10 10 POUCH in 1 CARTON contains a POUCH (58189-122-01)
1 NHRIC:58189-122-01 1 in 1 POUCH This package is contained within the CARTON (58189-122-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Premarket Notification K040019 06/01/2013
X-STATIC SILVERSEAL HYDROGEL DRESSING 3
Product Information
Product Type Item Code (Source) NHRIC:58189-130
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:58189-130-10 10 POUCH in 1 CARTON contains a POUCH (58189-130-01)
1 NHRIC:58189-130-01 1 in 1 POUCH This package is contained within the CARTON (58189-130-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Premarket Notification K040019 06/01/2013
HYDRESS
Product Information
Product Type Item Code (Source) NHRIC:58189-144
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:58189-144-10 10 POUCH in 1 CARTON contains a POUCH (58189-144-01)
1 NHRIC:58189-144-01 1 in 1 POUCH This package is contained within the CARTON (58189-144-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Exempt Device FRO 05/15/2013
Labeler — Alliqua Inc (872967679)

Revised: 05/2013 Alliqua Inc

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