| Primary Device ID | 10886982349897 |
| NIH Device Record Key | 515e1dde-7f58-41e3-b751-3f477a0342e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | SD03.211.120 |
| Catalog Number | SD03211120 |
| 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 | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886982349897 [Primary] |
| HTO | REAMER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10886982349897]
Moist Heat or Steam Sterilization
[10886982349897]
Moist Heat or Steam Sterilization
[10886982349897]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-01 |
| Device Publish Date | 2025-08-22 |
| 10886982349873 - NA | 2025-09-01 CANNULATED CIRCULAR REAMER 16MM |
| 10886982349880 - NA | 2025-09-01 CANNULATED CIRCULAR REAMER 18MM |
| 10886982349897 - NA | 2025-09-01CANNULATED CIRCULAR REAMER 20MM |
| 10886982349897 - NA | 2025-09-01 CANNULATED CIRCULAR REAMER 20MM |
| 10886982349903 - NA | 2025-09-01 CANNULATED CIRCULAR REAMER 22MM |
| 10886982350039 - NA | 2025-08-15 CRE DRILL GUIDE 15MM |
| 10886982350046 - NA | 2025-08-15 CRE DRILL GUIDE 18MM |
| 10886982350053 - NA | 2025-08-15 CRE DRILL GUIDE 20MM |
| 10886982350060 - NA | 2025-08-15 CRE DRILL GUIDE 25MM |