VERICEL CORPORATION

Address:64 Sidney St,CAMBRIDGE,MA,02139,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Container, Specimen Mailer And Storage, Temperature Controlled, Sterile (KDW) (2) Blood Specimen Collection Convenience Kit (Excludes Hiv) (PQD) (1) Cultured Epithelial Autograft (OCE) (1) Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (1)

Premarket Exempt

No Yes

Clear

Sterilization Tray - 00850037506095 Catalog Number :

Device Class : 2

Duns Number: 079745570

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

Blood Collection Kit - 00850037506170 Catalog Number :

Device Description : The Blood Collection Kit is intended to provide a way to collect and transport v The Blood Collection Kit is intended to provide a way to collect and transport venous blood samples to a biobanking facility. The Blood Collection Kit contains blood specimen collection devices and associated materials necessary to transport the samples to a biobanking facility. This includes two BD 10.0mL K2 EDTA (K2E) Plus Blood Collection Tubes (366643) and one VonSeal® 95kPA Biohazard Specimen Bag.

Device Class : 2

Duns Number: 079745570

Premarket Exempt : Yes

Product Code : PQD

Prescription Use : Yes

Device Count : 1

Skin Biopsy Transport Kit - 00860004093008 Catalog Number :

Device Description : The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of EPICEL - (Container, specimen mailer and storage, temperature controlled, sterile)

Device Class : 1

Duns Number: 079745570

Premarket Exempt : Yes

Product Code : KDW

Prescription Use : Yes

Device Count : 1

Cartilage Biopsy Transport Kit - 00860004093015 Catalog Number :

Device Description : The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live cartilage biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of MACI - (Container, specimen mailer and storage, temperature controlled, sterile)

Device Class : 1

Duns Number: 079745570

Premarket Exempt : Yes

Product Code : KDW

Prescription Use : Yes

Device Count : 1

Epicel (cultured epidermal autografts) - W41020AU201P0001 Catalog Number :

Device Description : Epicel (cultured epidermal autografts) is an aseptically processed wound dressin Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area.Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.

Device Class :

Duns Number: 079745570

Premarket Exempt : No

Product Code : OCE

Prescription Use : Yes

Device Count : 1

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