Omnia Medical TiBrid™- A/SA
TiBrid™-SA Bullet Trial, 10mm
10manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Tianjin (2), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Premier Guard Zhongshan Limited | Zhongshan | Guangdong | Contract manufacturer | 10 |
| Tonglu Qianyan Medtech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tianjin Water Source Tech Co., Ltd. | Tianjin | Tianjin | Manufacturer | 27 |
| Plasdent Shanghai Co., Ltd. | Shanghai | Shanghai | Manufacturer | 24 |
| Tianjin Medicines & Health Products IMP. & EXP. Corp. | Tianjin | Tianjin | Exporter | 16 |
| Orihealth Medical Products(Suzhou)Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Omnia Medical, United States |
|---|---|
| FDA product code | GCZ |
| Device type | Retainer, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Height 8 to 14 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17-5A-BT10 | Height 10 mm | In distribution |
| 17-5A-BT08 | Height 8 mm | In distribution |
| 17-5A-BT12 | Height 12 mm | In distribution |
| 17-5A-BT09 | Height 9 mm | In distribution |
| 17-5A-BT14 | Height 14 mm | In distribution |
| 17-5A-BT11 | Height 11 mm | In distribution |
| 17-5A-BT13 | Height 13 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Viscera Retainer, Fish | Adept-MED Intl., Inc. | 6 |
| Viscera Retainer Radiopaque Center Spine | Rainbow Medical Devices LLC | 4 |
| Matira Anterior Cervical System | Kalitec Direct, LLC | 3 |
| 14mm Distraction Pin-Double | Folsom Metal Products, Inc. | 2 |
| Surgeon Sturgeon | Flexbar Machine Corp. | 2 |
| 12mm Distraction Pin-Double | Folsom Metal Products, Inc. | 2 |
| 12mm Distraction Pin | Folsom Metal Products, Inc. | 2 |
| 14mm Distraction Pin | Folsom Metal Products, Inc. | 2 |
| Post Drill Guide Sleeve, 45mm | Toby Orthopaedics | 1 |
| LapPakOR | THE O R Company PTY Ltd | 1 |
| SurgiFish | Greer Medical, Inc. | 1 |
| Breast Implant Protector | Adept-MED Intl., Inc. | 1 |
Showing 12 of 15. All products under Retainer, Surgical
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.