| Primary Device ID | 07630345710390 |
| NIH Device Record Key | 2bf0a5ed-5fe6-42d6-94b0-1730116e74fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Glenoid Reconstruction System |
| Version Model Number | 04.01.0310 |
| Company DUNS | 488227125 |
| Company Name | Medacta International SA |
| 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 | 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 | 07630345710390 [Primary] |
| PHX | Shoulder Prosthesis, Reverse Configuration |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-06 |
| Device Publish Date | 2022-11-28 |
| 07630345710529 | GRS central screw - L30 |
| 07630345710512 | GRS central screw - L25 |
| 07630345710505 | GRS central screw - L20 |
| 07630345710499 | GRS central screw - L15 |
| 07630345710406 | GRS baseplate - Ø27x30 +6mm |
| 07630345710390 | GRS baseplate - Ø27x30 +3mm |
| 07630345710383 | GRS baseplate - Ø27x30 |
| 07630345710376 | GRS baseplate - Ø27x20 +6mm |
| 07630345710369 | GRS baseplate - Ø27x20 +3mm |
| 07630345710352 | GRS baseplate - Ø27x20 |
| 07630345710345 | GRS baseplate - Ø24.5x30 +6mm |
| 07630345710338 | GRS baseplate - Ø24.5x30 +3mm |
| 07630345710321 | GRS baseplate - Ø24.5x30 |
| 07630345710314 | GRS baseplate - Ø24.5x20 +6mm |
| 07630345710307 | GRS baseplate - Ø24.5x20 +3mm |
| 07630345710291 | GRS baseplate - Ø24.5x20 |