| Primary Device ID | 07630055304612 |
| NIH Device Record Key | 262182a7-ee52-417b-99b3-b1bbfe5ea057 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Positioning handle - M8x1 interface |
| Version Model Number | 75.70.057 |
| Catalog Number | 75.70.057 |
| 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 | 07630055304612 [Primary] |
| HWA | Impactor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630055304612]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-19 |
| Device Publish Date | 2024-02-09 |
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