| Primary Device ID | 07630055302564 |
| NIH Device Record Key | 938392e9-0976-4ec8-972c-eb6a34a3a8b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Straight reamer handle - Large AO - Dual coupling |
| Version Model Number | 50244550 |
| Catalog Number | 10-502-466-50 |
| 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 | 07630055302564 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
[07630055302564]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-16 |
| Device Publish Date | 2023-10-06 |
| 07630055301468 | Straight Reamer Handle for hip arthroplasty |
| 07630055301758 | Straight Reamer Handle for hip arthroplasty |
| 07630055301383 | Straight Reamer Handle - Large AO - Dual Coupling |
| 07630055302496 | Straight Reamer Handle for hip arthroplasty |
| 07630055302472 | Straight Reamer Handle for hip arthroplasty |
| 07630055301901 | Straight Reamer Handle for hip arthroplasty |
| 07630055304223 | Straight Acetabular Reamer Handle- for hip arthroplasty |
| 07630055302564 | Straight Acetabular Reamer Handle- for hip arthroplasty |