| Primary Device ID | 00860004093053 |
| NIH Device Record Key | c2d79286-b890-40e5-8edb-b609c3c33897 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MACI Arthroscopic Instruments |
| Version Model Number | 82027 |
| 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 | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00860004093053 [Primary] |
| NBH | Accessories, Arthroscopic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-03 |
| Device Publish Date | 2024-08-26 |
| 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 |