| Primary Device ID | 03760154008280 |
| NIH Device Record Key | 9c6646cc-2196-4ed7-9235-3e430dbf2384 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ComposiTCP™ |
| Version Model Number | Suture Anchor Punch Tap |
| Catalog Number | 110026112 |
| Company DUNS | 772462123 |
| Company Name | S.B.M |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 03760154008280 [Primary] |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2018-03-13 |
| 03760154007245 | Threaded anchor system Ø 6.5 mm with one Blue non-sliding suture and one White/Green sliding su |
| 03760154007238 | Threaded anchor system Ø 5.5 mm with one Blue non-sliding suture and one White/Green sliding su |
| 03760154007221 | Threaded anchor system Ø 4.5 mm with one Blue non-sliding suture and one White/Green sliding su |
| 03760154008266 | Threaded anchor system Ø 6.5 mm |
| 03760154008259 | Threaded anchor system Ø 5.5 mm |
| 03760154008242 | Threaded anchor system Ø 4.5 mm |
| 03760154008235 | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 6.5 mm |
| 03760154008228 | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 5.5 mm |
| 03760154008211 | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 4.5 mm |
| 03760154008280 | Ø 5.5 mm & Ø 6.5 mm suture anchor punch tap |
| 03760154008273 | Ø4.5 mm suture anchor punch tap |