| Primary Device ID | 07630055305015 |
| NIH Device Record Key | 431a0085-9793-45fd-b2b5-937fd0736691 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Positioning handle - M6x1 interface |
| Version Model Number | FH 271035 |
| Catalog Number | FH 271035 |
| 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 | 07630055305015 [Primary] |
| HWA | Impactor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
[07630055305015]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-05 |
| Device Publish Date | 2024-06-27 |
| 07630055305237 | Positioning handle assembly accessory for offset cup impactor M6x1 interface |
| 07630055305015 | Positioning handle assembly accessory for offset cup impactor M6x1 interface |