MACI: Package Insert and Label Information (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — NDC: 69866-1030-1 — Dish Label

Dish Label
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PRINCIPAL DISPLAY PANEL — NDC: 69866-1030-1 — Outer Bag Label

Outer Bag Label
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PRINCIPAL DISPLAY PANEL — NDC: 69866-1030-1 — Shipper Label

Shipper Label
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PRINCIPAL DISPLAY PANEL — NDC: 69866-1030-2 — Dish Label

Dish Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 69866-1030-2 — Outer Bag Label

Outer Bag Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 69866-1030-2 — Shipper Label

Shipper Label
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PRINCIPAL DISPLAY PANEL — NDC: 69866-1030-3 — Bottle Label

Dish Label
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PRINCIPAL DISPLAY PANEL — NDC: 69866-1030-4 — Outer Pouch Label

Outer Bag Label
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PRINCIPAL DISPLAY PANEL — NDC: 69866-1030-5 — Shipper Label

Shipper Label
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PRINCIPAL DISPLAY PANEL — NDC: 69866-1030-6 — Bottle Label

Dish Label
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PRINCIPAL DISPLAY PANEL — NDC: 69866-1030-7 — Outer Pouch Label

Outer Bag Label
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PRINCIPAL DISPLAY PANEL — NDC: 69866-1030-8 — Shipper Label

Shipper Label
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MACI autologous cultured chondrocytes implant
Product Information
Product Type Item Code (Source) NDC:69866-1030
Route of Administration INTRA-ARTICULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUTOLOGOUS CULTURED CHONDROCYTES (AUTOLOGOUS CULTURED CHONDROCYTES) AUTOLOGOUS CULTURED CHONDROCYTES 15000000
PORK COLLAGEN (PORK COLLAGEN) PORK COLLAGEN 15 cm2
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69866-1030-1 1 POUCH in 1 BOX contains a POUCH
1 1 CONTAINER in 1 POUCH This package is contained within the BOX (69866-1030-1) and contains a CONTAINER
1 1 IMPLANT in 1 CONTAINER This package is contained within a POUCH and a BOX (69866-1030-1)
2 NDC:69866-1030-2 1 POUCH in 1 BOX contains a POUCH
2 2 CONTAINER in 1 POUCH This package is contained within the BOX (69866-1030-2) and contains a CONTAINER
2 1 IMPLANT in 1 CONTAINER This package is contained within a POUCH and a BOX (69866-1030-2)
3 NDC:69866-1030-5 1 BAG in 1 BOX contains a BAG (69866-1030-4)
3 NDC:69866-1030-4 1 BOTTLE, PLASTIC in 1 BAG This package is contained within the BOX (69866-1030-5) and contains a BOTTLE, PLASTIC (69866-1030-3)
3 NDC:69866-1030-3 1 IMPLANT in 1 BOTTLE, PLASTIC This package is contained within a BAG (69866-1030-4) and a BOX (69866-1030-5)
4 NDC:69866-1030-8 2 BAG in 1 BOX contains a BAG (69866-1030-7)
4 NDC:69866-1030-7 1 BOTTLE, PLASTIC in 1 BAG This package is contained within the BOX (69866-1030-8) and contains a BOTTLE, PLASTIC (69866-1030-6)
4 NDC:69866-1030-6 1 IMPLANT in 1 BOTTLE, PLASTIC This package is contained within a BAG (69866-1030-7) and a BOX (69866-1030-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125603 06/09/2017
Labeler — Vericel Corporation (079745570)

Revised: 06/2021 Vericel Corporation

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