Gynex
64 catalogue numbers from 1010, listed by Gynex Corporation, United States, under Forceps, Biopsy, Gynecological. 11 manufacturers in China are registered for this product code.
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 | Gynex Corporation, United States |
|---|---|
| FDA product code | HFB |
| Device type | Forceps, Biopsy, Gynecological |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-06-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1010 | In distribution | |
| TT007 | In distribution | |
| 1205 | In distribution | |
| 1220 | In distribution | |
| 1200-40 | In distribution | |
| 1008 | In distribution | |
| 1025 | In distribution | |
| 1045 | In distribution | |
| 1022 | In distribution | |
| TB005 | In distribution | |
| 1230 | In distribution | |
| 1007 | In distribution | |
| 1200-15 | In distribution | |
| TT036 | In distribution | |
| TT030 | In distribution | |
| 1021 | In distribution | |
| 1210 | In distribution | |
| TT031 | In distribution | |
| TAU005 | In distribution | |
| TT010 | In distribution | |
| TB010 | In distribution | |
| 1035 | In distribution | |
| 1200-30 | In distribution | |
| 1026 | In distribution | |
| 1200-25 | In distribution | |
| TA005 | In distribution | |
| 1053 | In distribution | |
| 1235 | In distribution | |
| 1050 | In distribution | |
| 1005 | In distribution | |
| 1033 | In distribution | |
| 1200-10 | In distribution | |
| 1012 | In distribution | |
| 1014 | In distribution | |
| 1225 | In distribution | |
| 1200 | In distribution | |
| 1029 | In distribution | |
| 1037 | In distribution | |
| 1075 | In distribution | |
| TT011 | In distribution | |
| 1215 | In distribution | |
| 1006 | In distribution | |
| 1200-35 | In distribution | |
| TA010 | In distribution | |
| 1240 | In distribution | |
| 1070 | In distribution | |
| 1015 | In distribution | |
| TT035 | In distribution | |
| 1200-05 | In distribution | |
| 1030 | In distribution | |
| 1020 | In distribution | |
| 1027 | In distribution | |
| 1017 | In distribution | |
| 1065 | In distribution | |
| TT037 | In distribution | |
| TT005 | In distribution | |
| 1200-20 | In distribution | |
| TT006 | In distribution | |
| 1019 | In distribution | |
| TT032 | In distribution | |
| TAU010 | In distribution | |
| 1060 | In distribution | |
| 1039 | In distribution | |
| TT012 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoch | Endoch Inc | 160 |
| Marina Medical | Marina Medical Instruments, Inc. | 142 |
| 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 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 20 |
Showing 12 of 131. All products under Forceps, Biopsy, Gynecological
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.