| Primary Device ID | 07630055301901 |
| NIH Device Record Key | b09dfbae-432f-4cd3-a542-0c2f82d80e2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Straight reamer handle - Large AO - Dual Coupling |
| Version Model Number | 50244550 |
| Catalog Number | 50244550 |
| 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 | 07630055301901 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630055301901]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-01 |
| Device Publish Date | 2020-04-23 |
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| 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 |