| Primary Device ID | H679553714130 |
| NIH Device Record Key | 750e9f65-f76d-4f82-85ef-802805a722a8 |
| Commercial Distribution Discontinuation | 2020-06-28 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | 5537-14/13 |
| Catalog Number | 55371413 |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886982241382 [Primary] |
| HIBCC | H679553714130 [Secondary] |
| KWT | PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[H679553714130]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-06-29 |
| Device Publish Date | 2015-09-14 |
| 10886982297280 - NA | 2024-09-11 SCHANZ PIN REMOVAL TOOL |
| H9814871830 - Click'X | 2024-09-11 7.0MM TI CLICK'X® MONOAXIAL PEDICLE SCREW 90MM THRD LENGTH |
| H9812982060 - NA | 2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE |
| H6792042280 - NA | 2024-07-24 3.5MM SHAFT SCREW 28MM |
| H6792042320 - NA | 2024-07-24 3.5MM SHAFT SCREW 32MM |
| H6792042340 - NA | 2024-07-24 3.5MM SHAFT SCREW 34MM |
| H6792042360 - NA | 2024-07-24 3.5MM SHAFT SCREW 36MM |
| H6792042380 - NA | 2024-07-24 3.5MM SHAFT SCREW 38MM |