HiVac™ 7 Bone Cement Mixing and Delivery System
GUDID 25060238200213
Bone Cement Mixing and Delivery System
SUMMIT MEDICAL LIMITED
Orthopaedic cement preparation/delivery kit| Primary Device ID | 25060238200213 |
| NIH Device Record Key | 52bf8324-26fb-4135-8d98-9b2e761ca5b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HiVac™ 7 Bone Cement Mixing and Delivery System |
| Version Model Number | C701 |
| 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 | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15060238200216 [Primary] |
| GS1 | 25060238200213 [Package] Contains: 15060238200216 Package: Carton [10 Units] In Commercial Distribution |
FDA Product Code
| KIH | Dispenser, Cement |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
Devices Manufactured by SUMMIT MEDICAL LIMITED
| 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 |
Trademark Results [HiVac]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HIVAC 76312288 2873143 Dead/Cancelled |
SUMMIT MEDICAL LIMITED 2001-09-14 |
 HIVAC 74347705 not registered Dead/Abandoned |
WOODWARD-CLYDE CONSULTANTS 1993-01-12 |
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