HiVac™ Bowl Bone Cement Mixing System
GUDID 25060238200282
HiVac™ Bowl Bone Cement Mixing System
SUMMIT MEDICAL LIMITED
Orthopaedic cement preparation/delivery kit| Primary Device ID | 25060238200282 |
| NIH Device Record Key | ff6854fb-f264-46b0-86ae-a2aa12162ce4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HiVac™ Bowl Bone Cement Mixing System |
| Version Model Number | B713 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15060238200285 [Primary] |
| GS1 | 25060238200282 [Package] Contains: 15060238200285 Package: Carton [15 Units] In Commercial Distribution |
FDA Product Code
| JDZ | Mixer, Cement, For Clinical Use |
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 | 2021-12-09 |
| Device Publish Date | 2021-12-01 |
Devices Manufactured by SUMMIT MEDICAL LIMITED
| 25060238201593 - Femoral Cement Pressuriser | 2025-01-20 Femoral Cement Pressuriser |
| 25060238201630 - HiVac™ 7 Triple Mix | 2025-01-20 HiVac™ 7 Triple Mix |
| 25060238201654 - HiVac™ 7 with Femoral Cement Pressuriser | 2025-01-20 HiVac™ 7 with Femoral Cement Pressuriser |
| 25060238201678 - HiVac™ Syringe | 2025-01-20 HiVac™ Syringe |
| 25060238201685 - HiVac™ Syringe | 2025-01-20 HiVac™ Syringe |
| 25060238201715 - 9mm Nozzle With Nozzle Extruder | 2025-01-20 9mm Nozzle With Nozzle Extruder |
| 25060238201722 - Quick-Vac® Vacuum Mixing Bowl | 2025-01-20 Quick-Vac® Vacuum Mixing Bowl |
| 25060238201739 - Quick-Vac® Vacuum Mixing Bowl | 2025-01-20 Quick-Vac® Vacuum Mixing Bowl |
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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