Viscera Retainer Radiopaque Center Spine
One unit packaged in a Poly/Poly Chevron sealed pouch, Gama Sterilized with a 3 year shelf life. The Viscera Retainer is made up of green plastic and is flat on one side with ribs on the…
One unit packaged in a Poly/Poly Chevron sealed pouch, Gama Sterilized with a 3 year shelf life. The Viscera Retainer is made up of green plastic and is flat on one side with ribs on the other to support placement in viscera region with a over molded radiopaque center spine up the middle of the unit for additional support for placement and extraction. The retainer has an attached pull cord and ring for easy removal when suturing is about complete.
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 | Rainbow Medical Devices LLC, United States |
|---|---|
| FDA product code | GCZ |
| Device type | Retainer, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-01-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Corrugate box of 150, corrugate box of 10, corrugated box of 10 |
| Sizes | Width 5.6 to 7 in; height 8.5 to 10.5 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Medium | Width 6 in | In distribution |
| Small | Width 5.6 in | In distribution |
| Large | Width 6.5 in | In distribution |
| X-Large | Width 7 in | 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 |
| 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.