Trinity Sterile, Inc.
Econo Sterile Oval Biopsy FCP 3X7MM STER10
11manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hangzhou Stellarmed Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 15 |
| Zhuji Pengtian Medical Instrument Co., Ltd. | Zhuji | Zhejiang | Manufacturer | 10 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Jiangsu Jiyuan Medical Technology Co., Ltd. | Taizhou | Jiangsu | Specification developer | 3 |
Record
| Listed by | Trinity Sterile, Inc., United States |
|---|---|
| FDA product code | HFB |
| Device type | Forceps, Biopsy, Gynecological |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Record published | 2024-12-16 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 96-4137M | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoch | Endoch Inc | 160 |
| Marina Medical | Marina Medical Instruments, Inc. | 142 |
| Gynex | Gynex Corporation | 64 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 52 |
| Aesculap | Aesculap AG | 49 |
| Novo Surgical | Novo Surgical, Inc. | 44 |
| Hayden Medical | Hayden Medical Inc | 37 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 34 |
| BR Surgical, LLC | BR Surgical LLC | 33 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 29 |
| Raw Surgical Corporation | RAW Surgical Corporation | 26 |
| Millennium | Avalign Technologies, Inc. | 24 |
Showing 12 of 131. All products under Forceps, Biopsy, Gynecological
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Sklar Corporation | UDI-DI | 2024-12-03 | Class II | Under Investigation by firm | Reports of various packaging issues that may result in a breach of the sterile barrier. | 0 units |
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.