| Primary Device ID | 07611819943490 |
| NIH Device Record Key | 5af9613e-25dd-4f13-8610-00aca3e83ed2 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | E5115-7 |
| Catalog Number | E51157 |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| 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 | 07611819943490 [Direct Marking] |
| GS1 | 10886982001047 [Primary] |
| HIBCC | H679E511570R [Secondary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07611819943490]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2026-02-09 |
| Device Publish Date | 2017-02-20 |
| H981PDL432F - NA | 2026-02-09 INLAY PUSHER-MEDIUM |
| H981PDL434H - NA | 2026-02-09 INLAY PUSHER-LARGE |
| 07611819995796 - NA | 2026-02-09 TAMP |
| 07611819943490 - NA | 2026-02-09HEAD IMPACTOR |
| 07611819943490 - NA | 2026-02-09 HEAD IMPACTOR |
| H679E51157P09 - NA | 2026-02-09 PLASTIC TIP FOR HEAD IMPACTOR |
| 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 |