| Primary Device ID | 08058964727862 |
| NIH Device Record Key | e02f8670-3bfb-4087-ae93-36b2472f3a0f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpaceFlex Knee Trial |
| Version Model Number | 900201 |
| Company DUNS | 431529195 |
| Company Name | G21 SRL |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08058964727862 [Primary] |
| HWT | Template |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-18 |
| Device Publish Date | 2024-10-10 |
| 08058964727855 - PicoMix Gun | 2024-10-30 |
| 08058964724687 - V-Access | 2024-10-24 |
| 08058964725356 - V-Access | 2024-10-24 |
| 08058964725363 - V-Access | 2024-10-24 |
| 08058964725417 - V-Access | 2024-10-24 |
| 08058964726797 - SpaceFlex Shoulder Instrument Kit | 2024-10-24 |
| 08058964723758 - Disp. Mixing Bowl-O | 2024-10-22 OPEN MIXING SYSTEM FOR BONE CEMENT PREPARATION |
| 08058964724427 - KeyFix Bone Drill | 2024-10-22 |