| Primary Device ID | 15060238201848 |
| NIH Device Record Key | 9a826336-f333-42b8-a279-7e4d5c3bee3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bone Cement Delivery Gun |
| Version Model Number | H719 |
| Catalog Number | H719 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| Phone | +441451821311 |
| info@summit-medical.co.uk | |
| Phone | +441451821311 |
| info@summit-medical.co.uk | |
| Phone | +441451821311 |
| info@summit-medical.co.uk | |
| Phone | +441451821311 |
| info@summit-medical.co.uk | |
| Phone | +441451821311 |
| info@summit-medical.co.uk | |
| Phone | +441451821311 |
| info@summit-medical.co.uk | |
| Phone | +441451821311 |
| info@summit-medical.co.uk | |
| Phone | +441451821311 |
| info@summit-medical.co.uk | |
| Phone | +441451821311 |
| info@summit-medical.co.uk | |
| Phone | +441451821311 |
| info@summit-medical.co.uk | |
| Phone | +441451821311 |
| info@summit-medical.co.uk | |
| Phone | +441451821311 |
| info@summit-medical.co.uk | |
| Phone | +441451821311 |
| info@summit-medical.co.uk |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15060238201848 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[15060238201848]
Moist Heat or Steam Sterilization
[15060238201848]
Moist Heat or Steam Sterilization
[15060238201848]
Moist Heat or Steam Sterilization
[15060238201848]
Moist Heat or Steam Sterilization
[15060238201848]
Moist Heat or Steam Sterilization
[15060238201848]
Moist Heat or Steam Sterilization
[15060238201848]
Moist Heat or Steam Sterilization
[15060238201848]
Moist Heat or Steam Sterilization
[15060238201848]
Moist Heat or Steam Sterilization
[15060238201848]
Moist Heat or Steam Sterilization
[15060238201848]
Moist Heat or Steam Sterilization
[15060238201848]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-20 |
| Device Publish Date | 2025-01-10 |
| 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 |