Breast Implant Protector
Catalogue number 3208, listed by Adept-MED Intl., Inc., United States, under Retainer, Surgical. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
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 | Adept-MED Intl., Inc., United States |
|---|---|
| FDA product code | GCZ |
| Device type | Retainer, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| 510(k) | K893870 |
| Record published | 2023-02-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3208 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Omnia Medical TiBrid™- A/SA | Omnia Medical | 7 |
| 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 |
Showing 12 of 15. All products under Retainer, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K893870 | 1989-07-14 |
| K870809 | 1987-03-19 |
| K802806 | 1981-01-23 |
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.