| Primary Device ID | 07611819926356 |
| NIH Device Record Key | e55dd4c5-b03b-4dca-8ddc-4cf8dfd7e4bd |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 05.001.064 |
| Catalog Number | 05001064 |
| Company DUNS | 486711679 |
| Company Name | Synthes GmbH |
| 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 | 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 | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07611819926356 [Direct Marking] |
| GS1 | 10886982128874 [Primary] |
| HIBCC | H679050010640 [Secondary] |
| ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-04-18 |
| Device Publish Date | 2016-06-30 |
| 10886982348326 - NA | 2025-07-08 SCREW RACK 3.0 & 4.0 |
| 10887587078434 - NA | 2025-07-03 REDUCTION FORCEPS W/ POINTS |
| 10886982343994 - NA | 2025-07-01 Ø14MM HOLLOW REAMER - FRN |
| 07611819642669 - NA | 2025-06-27 130 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING |
| 07611819642676 - NA | 2025-06-27 125 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING |
| 07611819655522 - NA | 2025-06-27 135 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING |
| 10886982348159 - NA | 2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/175MM/HA STER |
| 10886982348166 - NA | 2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/250MM/HA STER |