| Primary Device ID | 25060238201326 |
| NIH Device Record Key | 1792d9e3-f12e-4d7b-9f01-485e45a15e3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spatula & Curette Pack |
| Version Model Number | SC01 |
| Company DUNS | 221751311 |
| Company Name | SUMMIT MEDICAL LIMITED |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 15060238201329 [Primary] |
| GS1 | 25060238201326 [Package] Contains: 15060238201329 Package: Carton [10 Units] In Commercial Distribution |
| HTF | Curette |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-31 |
| Device Publish Date | 2022-08-23 |
| 25060238201609 - 6mm Slim Flexible Nozzle | 2024-05-30 6mm Slim Flexible Nozzle |
| 25060238201616 - HiVac™ 7 | 2024-05-28 Mixing and Delivery System |
| 25060238201357 - SmartMix™ Vacuum Syringe | 2024-05-06 Bone cement mixing and delivery system |
| 25060238201364 - SmartMix™ Vacuum Syringe Plus | 2024-05-06 Bone cement mixing and delivery system |
| 25060238201371 - SmartMix™ Delivery Gun | 2024-05-06 Bone Cement Delivery Gun |
| 25060238201418 - SmartMix™ Syringe Kit | 2024-05-06 Bone cement delivery system |
| 25060238201586 - SmartMix™ 9mm Narrow Nozzle | 2024-05-06 9mm Narrow Straight Nozzle |
| 15060238200148 - SmartMix Vacuum Footpump and Airhose | 2023-02-17 SmartMix Vacuum Footpump and Airhose |