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

Primary Device ID	00850037506132
NIH Device Record Key	127c741e-c24c-43fa-aa6b-5ac48fcb0d3d
Commercial Distribution Status	In Commercial Distribution
Brand Name	MACI Surgical Implantation Kit
Version Model Number	N/A
Company DUNS	079745570
Company Name	VERICEL CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850037506132 [Primary]

FDA Product Code

FSM	Tray, Surgical, Instrument