| Primary Device ID | 07612334216809 |
| NIH Device Record Key | 8fe15cc9-8856-4404-b427-f3d811a786dd |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 03.164.027 |
| Catalog Number | 03164027 |
| Company DUNS | 486711679 |
| Company Name | Synthes GmbH |
| 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 | false |
| 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 |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07612334216809 [Direct Marking] |
| GS1 | 10886982311092 [Primary] |
| HXX | SCREWDRIVER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07612334216809]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-07 |
| Device Publish Date | 2022-11-29 |
| 10886982351586 - NA | 2026-02-18 XL25 SOLID SCREWDRIVER 325MM LENGTH |
| 10886982351593 - NA | 2026-02-18 XL25 SOLID SCREWDRIVER 250.5MM LENGTH |
| 10886982362186 - NA | 2026-01-19 CONNECTOR UNIT RFNA PROXIMAL AIMING DEVICE |
| 10886982362193 - NA | 2026-01-19 CALIBRATION UNIT RFNA PROXIMAL AIMING DEVICE |
| 10886982362209 - NA | 2026-01-19 ANGULAR ADJUSTMENT LOCK KNOB RFNA PROXIMAL AIMING DEVICE |
| 10886982362216 - NA | 2026-01-19 LINEAR ADJUSTMENT LOCK KNOB RFNA PROXIMAL AIMING DEVICE |
| 10886982361257 - VOLT | 2025-12-24 REPLACEMENT BRKTS F/60.529.005 |
| H9810460002902S0 - NA | 2025-12-11 TI DISTRACTOR PINS-16MM STERILE |