| Primary Device ID | 07630055304575 |
| NIH Device Record Key | 4670bbe5-f90d-43c3-b93f-210bd7f3a0b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Offset Cup Impactor - M10x1.5 interface |
| Version Model Number | 50341803 |
| Catalog Number | 50341803 |
| 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 | 07630055304575 [Primary] |
| HWA | Impactor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630055304575]
Moist Heat or Steam Sterilization
[07630055304575]
Moist Heat or Steam Sterilization
[07630055304575]
Moist Heat or Steam Sterilization
[07630055304575]
Moist Heat or Steam Sterilization
[07630055304575]
Moist Heat or Steam Sterilization
[07630055304575]
Moist Heat or Steam Sterilization
[07630055304575]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-13 |
| Device Publish Date | 2022-06-03 |
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| 07630055302670 | Offset Cup Impactor for hip arthroplasty |
| 07630055304575 | Offset Cup Impactor for hip arthroplasty |
| 07630055304988 | Offset Cup Impactor for hip arthroplasty |
| 07630055305107 | Offset Cup Impactor for hip arthroplasty |