| Primary Device ID | 04042409398087 |
| NIH Device Record Key | 633a8a6d-fded-49e5-b550-37aeda8dc894 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | SP 4035-30-2 |
| Catalog Number | SP 4035-30-2 |
| Company DUNS | 328420633 |
| Company Name | aap Implantate AG |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 | 04042409398087 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04042409398087]
Moist Heat or Steam Sterilization
[04042409398087]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-03 |
| Device Publish Date | 2020-03-26 |
| 04042409240447 - NA | 2025-01-16 Drill CS 4.0, ø2.5, L 130, quick coupling, single use |
| 04042409240454 - NA | 2025-01-16 Drill CS 4.5, ø3.0, L 130, quick coupling, single use |
| 04042409240461 - NA | 2025-01-16 Drill CS 4.0, ø4.0, L 130, quick coupling, single use |
| 04042409240478 - NA | 2025-01-16 Drill CS 4.5, ø4.5, L 130, quick coupling, single use |
| 04042409240485 - NA | 2025-01-16 Cannulated drill CS 6.5, ø4.4, L 220, Hudson, single use |
| 04042409240508 - NA | 2025-01-16 Countersink CS 6.5/7.5, Hudson |
| 04042409240713 - NA | 2025-01-16 Parallel guide for K-wires, CS 6.5/7.5 |
| 04042409240744 - NA | 2025-01-16 Screwdriver cannulated CS 6.5/7.5, hex, ø5.0, Hudson |