Fentex
Retractor by Fisch semi sharp, wide opening 16.5 cm, 3 x 3 prongs
3manufacturers in China registered for this device type
54catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Fentex medical GmbH |
|---|---|
| FDA product code | KAL |
| Device type | Retractor, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Premarket notification | Exempt |
| Record published | 2022-12-12 |
| Record revised | 2026-07-21 (version 2) |
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 |
| Distribution end date | 2026-07-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100320FX | In distribution | |
| 100211FX | In distribution | |
| 103017FX | In distribution | |
| 100420FX | In distribution | |
| 102717FX | In distribution | |
| 101211FX | In distribution | |
| 100216FX | In distribution | |
| 102617FX | In distribution | |
| 100513FX | In distribution | |
| 101402FX | In distribution | |
| 101311FX | In distribution | |
| 100113FX | In distribution | |
| 102817FX | In distribution | |
| 100411FX | In distribution | |
| 100213FX | In distribution | |
| 101313FX | In distribution | |
| 101111FX | In distribution | |
| 102618FX | In distribution | |
| 102413FX | In distribution | |
| 100311FX | In distribution | |
| 100416FX | In distribution | |
| 101213FX | In distribution | |
| 102917FX | In distribution | |
| 101911FX | In distribution | |
| 100116FX | In distribution | |
| 100316FX | In distribution | |
| 100313FX | In distribution | |
| 100111FX | In distribution | |
| 101500FX | In distribution | |
| 100413FX | In distribution | |
| 102411FX | In distribution | |
| 102011FX | In distribution | |
| 102511FX | In distribution | |
| 102513FX | In distribution | |
| 101401FX | In distribution | |
| 101113FX | In distribution | |
| 540512FX | Withdrawn | |
| 540517FX | Withdrawn | |
| 540504FX | Withdrawn | |
| 540529FX | Withdrawn | |
| 540516FX | Withdrawn | |
| 540521FX | Withdrawn | |
| 540519FX | Withdrawn | |
| 540528FX | Withdrawn | |
| 540508FX | Withdrawn | |
| 540513FX | Withdrawn | |
| 540524FX | Withdrawn | |
| 540525FX | Withdrawn | |
| 540509FX | Withdrawn | |
| 540518FX | Withdrawn | |
| 540520FX | Withdrawn | |
| 540522FX | Withdrawn | |
| 540511FX | Withdrawn | |
| 540514FX | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Steris Corporation | 138 |
| Ambler Surgical | Ambler Surgical, LLC | 105 |
| Pilling | Teleflex Medical LLC | 90 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 89 |
| Boss Instruments | Boss Instruments, Ltd. | 61 |
| Avalign | Avalign Technologies, Inc. | 54 |
| Novo Surgical | Novo Surgical, Inc. | 52 |
| Millennium | Avalign Technologies, Inc. | 47 |
| Aesculap | Aesculap AG | 46 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 43 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 42 |
| HNM Medical | HNM Stainless, LLC. | 39 |
Showing 12 of 80. All products under Retractor, Ent
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.