MACI Surgical Implantation Kit

GUDID 00850037506132

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 (32-705), manufactured by Symmetry Surgical, Inc.; 2 - Toothless Adsons (30-1185), manufactured by Symmetry Surgical, Inc.; 1 - 4.5mm Ring Curette (8435.902), manufactured by Richard Wolf Medical Instruments Corp.; 1 - 6.0mm Ring Curette (8435.903), manufactured by Richard Wolf Medical Instruments Corp.; 1 - Mallet (FL072K), manufactured by Aesculap, Inc.; 1 - Cutter Oval 13X20mm (FR730R), manufactured by Aesculap, Inc.; 1 - Cutter Oval 15X23mm (FR731R), manufactured by Aesculap, Inc.; 1 - Cutter Oval 20X25mm (FR722R), manufactured by Aesculap, Inc.; 1 - Cutter Oval 22X32mm (FR723R), manufactured by Aesculap, Inc.; 1 - Cutter Round D15mm (FR721R), manufactured by Aesculap, Inc.; 1 - Cutter Round D28mm (FR737R), manufactured by Aesculap, Inc.; 1 - Cutter Oblong 10X30mm (FR738R), manufactured by Aesculap, Inc.;

VERICEL CORPORATION

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00850037506132
NIH Device Record Key127c741e-c24c-43fa-aa6b-5ac48fcb0d3d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMACI Surgical Implantation Kit
Version Model NumberN/A
Company DUNS079745570
Company NameVERICEL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850037506132 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850037506132]

Moist Heat or Steam Sterilization

[00850037506132]

Moist Heat or Steam Sterilization

[00850037506132]

Moist Heat or Steam Sterilization

[00850037506132]

Moist Heat or Steam Sterilization

[00850037506132]

Moist Heat or Steam Sterilization

[00850037506132]

Moist Heat or Steam Sterilization

[00850037506132]

Moist Heat or Steam Sterilization

[00850037506132]

Moist Heat or Steam Sterilization

[00850037506132]

Moist Heat or Steam Sterilization

[00850037506132]

Moist Heat or Steam Sterilization

[00850037506132]

Moist Heat or Steam Sterilization

[00850037506132]

Moist Heat or Steam Sterilization

[00850037506132]

Moist Heat or Steam Sterilization

[00850037506132]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-17
Device Publish Date2022-11-09

Devices Manufactured by VERICEL CORPORATION

00850037506057 - MACI Arthroscopic Instruments2024-09-26 18mm V-Shuttle delivery device
00850037506224 - MACI Arthroscopic Instruments2024-09-26 18mm V-Shuttle and Two-Pack MACI Applicator Kit
00850037506262 - MACI Arthroscopic Instruments2024-09-26 17 mm x 28 mm Max Arthroscopic Cutter and 17 mm x 28 mm MACI Cutter Kit
00850037506002 - MACI Arthroscopic Instruments2024-09-03 MACI Applicator
00850037506019 - MACI Arthroscopic Instruments2024-09-03 15mm V-Shuttle delivery device
00850037506026 - MACI Arthroscopic Instruments2024-09-03 6.5mm Open-ring curette
00850037506033 - MACI Arthroscopic Instruments2024-09-03 3.6mm Rake curette
00850037506040 - MACI Arthroscopic Instruments2024-09-03 4mm x 5mm Square curette
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