| Primary Device ID | H981U446401602S0 |
| NIH Device Record Key | 1260f403-5d97-4adb-a056-8bad833c6924 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | U44-640-16-02S |
| Catalog Number | U446401602S |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| Device Count | 2 |
| 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 | 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 | |
| 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 | 20705034711062 [Primary] |
| GS1 | 80705034711064 [Unit of Use] |
| HIBCC | H981U446401602S0 [Secondary] |
| HWD | STARTER, BONE SCREW |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-18 |
| Device Publish Date | 2019-01-18 |
| 10886982293060 - NA | 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 60MM/ XL25 |
| 10886982293237 - NA | 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 30MM/ XL25 |
| 10886982293244 - NA | 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 32MM/ XL25 |
| 10886982293251 - NA | 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 34MM/ XL25 |
| 10886982293268 - NA | 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 36MM/ XL25 |
| 10886982293275 - NA | 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 38MM/ XL25 |
| 10886982293282 - NA | 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 40MM/ XL25 |
| 10886982293299 - NA | 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 42MM/ XL25 |