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Vericel Corporation

Matched from indexed company URL: VERICEL CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12262303002836339Vericel Corporation1N2026-01-0164 Sidney St CAMBRIDGE MA US 02139

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1911312030360801K171520SteriZign Signatur Device Protection SystemKCT2018-02-07
1911311281449976BK050036
1911311908032665BH990200
1911311663899700
1911311021009451
1911311143187557
1911311228292496
1911311328361543
1911311483453324
1911311583759381
1911311818322529
1911311819864084
1911311975416674
1911311976362654
1911312036809140

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KCT12018-02-07

NDC#

MACI

Vericel Corporation

autologous cultured chondrocytes

NEXOBRID

Vericel Corporation

ANACAULASE-BCDB

NEXOBRID

Vericel Corporation

ANACAULASE-BCDB

NEXOBRID

Vericel Corporation

ANACAULASE-BCDB

GUDID#

MACI Surgical Implantation Kit - The MACI Surgical Implantation Kit is intended to assist with MACI® (autologous cultured chondrocytes on porcine collagen membrane) knee surgery. The kit contains instruments to assist surgeons with preparing the defect, cutting the implant, and transferring the implant.The MACI Surgical Implantation Kit contains:1 - Sterilization Tray;1 - Silicone Cutting Block, Single Use Only;1 - Tungsten Carbide Scissors, manufactured by Symmetry Surgical, Inc.;2 - Toothless Adsons, manufactured by Symmetry Surgical, Inc.;1 - 4.5mm Ring Curette, manufactured by Richard Wolf Medical Instruments Corp.; 1 - 6.0mm Ring Curette, manufactured by Richard Wolf Medical Instruments Corp.; 1 - Mallet, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oval 13X20mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oval 15X23mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oval 20X25mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oval 22X32mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Round D15mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Round D28mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oblong 10X30mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC

VERICEL CORPORATION

2022-11-09

Epicel (cultured epidermal autografts) - 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 a minimum of 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.

VERICEL CORPORATION

2024-02-05

Epicel (cultured epidermal autografts) - 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.

VERICEL CORPORATION

2017-11-17