MACI Arthroscopic Instruments N/A

GUDID 10850037506009

MACI Applicators, Two-Pack

VERICEL CORPORATION

Orthopaedic graft inserter, single-use

• Primary Device ID: 10850037506009
• NIH Device Record Key: 4bcec48b-9007-49f4-9384-5001f1bfce82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MACI Arthroscopic Instruments
• Version Model Number: 82039
• Catalog Number: N/A
• Company DUNS: 079745570
• Company Name: VERICEL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850037506009 [Primary]

FDA Product Code

• HXG: Tamp

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-03
• Device Publish Date: 2024-08-26

On-Brand Devices [MACI Arthroscopic Instruments]

• 10850037506009: MACI Applicators, Two-Pack
• 00860004093091: 17 mm x 28 mm MACI Cutter
• 00860004093084: 14 mm x 26 mm MACI Cutter
• 00860004093077: 12 mm x 21 mm MACI Cutter
• 00860004093060: 17 mm x 28 mm Max Arthroscopic Cutter
• 00860004093053: 14 mm x 26 mm Max Arthroscopic Cutter
• 00860004093046: 12 mm x 21 mm Min arthroscopic cutter
• 00860004093039: 18mm x 4cm Cannula assembly
• 00860004093022: 15mm x 4cm Cannula Assembly
• 00850037506279: MACI Arthroscopic Cutting Block
• 00850037506255: 14 mm x 26 mm Max Arthroscopic Cutter and 14 mm x 26 mm MACI Cutter Kit
• 00850037506248: 14 mm x 26 mm Min Arthroscopic Cutter and 14 mm x 26 mm MACI Cutter Kit
• 00850037506231: 12 mm x 21 mm Min Arthroscopic Cutter and 12 mm x 21 mm MACI Cutter Kit
• 00850037506217: 15mm V-Shuttle and Two-Pack MACI Applicator Kit
• 00850037506088: 15mm x 3cm Cannula Assembly
• 00850037506064: 14 mm x 26 mm Min arthroscopic cutter
• 00850037506040: 4mm x 5mm Square curette
• 00850037506033: 3.6mm Rake curette
• 00850037506026: 6.5mm Open-ring curette
• 00850037506019: 15mm V-Shuttle delivery device
• 00850037506002: MACI Applicator
• 00850037506262: 17 mm x 28 mm Max Arthroscopic Cutter and 17 mm x 28 mm MACI Cutter Kit
• 00850037506224: 18mm V-Shuttle and Two-Pack MACI Applicator Kit
• 00850037506057: 18mm V-Shuttle delivery device