| Primary Device ID | 08058964726483 |
| NIH Device Record Key | 0e6268de-5404-4c60-b3c4-2ff35392713e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WKK First Access Needle |
| Version Model Number | 900086 |
| 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 | 08058964726483 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-06 |
| Device Publish Date | 2025-02-26 |
| 08058964729217 - CeMend Shoulder Spacer | 2025-12-29 The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stain |
| 08058964729224 - CeMend Shoulder Spacer | 2025-12-29 The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stain |
| 08058964729231 - CeMend Shoulder Spacer | 2025-12-29 The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stain |
| 08058964729248 - CeMend Shoulder Spacer | 2025-12-29 The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stain |
| 08058964729255 - CeMend Shoulder Spacer Reamer Tray | 2025-12-29 Tray |
| 08058964729262 - Reamer T-handle | 2025-12-29 T-handle for reamer |
| 08058964729279 - CeMend Reamer 8mm | 2025-12-29 Reamer with diameter 8mm |
| 08058964729286 - CeMend Reamer 10mm | 2025-12-29 Reamer with diameter 10mm |