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MACI Surgical Implantation Kit

FDA UDI

Class I (US FDA UDI)

by Vericel Corporation

Identity

Trade Name
MACI Surgical Implantation Kit FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
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 FDA UDI
Model / Reference
N/A FDA UDI
Description
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 FDA UDI

Identifiers

Primary DI / UDI-DI
00850037506132 FDA UDI
FDA Product Code
FSM FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

MACI Surgical Implantation Kit by Vericel Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vericel Corporation

Sources (1)

  • FDA UDI 127c741e-c24c-43fa-aa6b-5ac48fcb0d3d 33 fields · synced May 30, 2026