| Primary Device ID | 07630055307057 |
| NIH Device Record Key | e40452f1-fca0-4298-8578-d057e5aa7237 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Offset reamer handle - Stryker Z/H - Tri coupling |
| Version Model Number | 2016REAM |
| Catalog Number | 50244512 |
| Company DUNS | 485098284 |
| Company Name | Incipio Devices SA |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630055307057 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630055307057]
Moist Heat or Steam Sterilization
[07630055307057]
Moist Heat or Steam Sterilization
[07630055307057]
Moist Heat or Steam Sterilization
[07630055307057]
Moist Heat or Steam Sterilization
[07630055307057]
Moist Heat or Steam Sterilization
[07630055307057]
Moist Heat or Steam Sterilization
[07630055307057]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-12 |
| Device Publish Date | 2026-02-04 |
| 07630055303066 | Offset Reamer Handle for hip arthroplasty |
| 07630055304698 | Offset Reamer Handle for hip arthroplasty |
| 07630055305800 | 30° Offset Reamer Handle for hip arthroplasty |
| 07630055307057 | 30° Offset Reamer Handle for hip arthroplasty |