| Primary Device ID | 07630055306159 |
| NIH Device Record Key | 8c426105-d745-44d6-8803-1284e6d8df1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Straight reamer handle - Hudson - Tri coupling (NL) |
| Version Model Number | 50244565 |
| Catalog Number | 50244565 |
| 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 | 07630055306159 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630055306159]
Moist Heat or Steam Sterilization
[07630055306159]
Moist Heat or Steam Sterilization
[07630055306159]
Moist Heat or Steam Sterilization
[07630055306159]
Moist Heat or Steam Sterilization
[07630055306159]
Moist Heat or Steam Sterilization
[07630055306159]
Moist Heat or Steam Sterilization
[07630055306159]
Moist Heat or Steam Sterilization
[07630055306159]
Moist Heat or Steam Sterilization
[07630055306159]
Moist Heat or Steam Sterilization
[07630055306159]
Moist Heat or Steam Sterilization
[07630055306159]
Moist Heat or Steam Sterilization
[07630055306159]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-08 |
| Device Publish Date | 2025-11-28 |
| 07630055306968 - Offset reamer handle - large AO - Dual Coupling | 2026-01-08 30° Offset Reamer Handle for hip arthroplasty |
| 07630055306975 - Straight reamer handle - Large AO - Dual coupling | 2026-01-08 Straight Acetabular Reamer Handle- for hip arthroplasty |
| 07630055307262 - Cup Reamer Size 42 | 2025-12-29 Acetabular Reamer |
| 07630055307279 - Cup Reamer Size 44 | 2025-12-29 Acetabular Reamer |
| 07630055307286 - Cup Reamer Size 46 | 2025-12-29 Acetabular Reamer |
| 07630055307293 - Cup Reamer Size 48 | 2025-12-29 Acetabular Reamer |
| 07630055307309 - Cup Reamer Size 50 | 2025-12-29 Acetabular Reamer |
| 07630055307316 - Cup Reamer Size 52 | 2025-12-29 Acetabular Reamer |