Flex
Tongue Blade, Textured, 80-110MM X 40MM Wide, Right Exposure, Radius 130MM
3manufacturers in China registered for this device type
28catalogue 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 | Medrobotics Corporation, United States |
|---|---|
| FDA product code | KAL |
| Device type | Retractor, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Premarket notification | Exempt |
| Record published | 2019-10-30 |
| Record revised | 2020-05-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50149PKG | In distribution | |
| 50124PKG | In distribution | |
| 50226PKG | In distribution | |
| 50203PKG | In distribution | |
| 50129PKG | In distribution | |
| 50208PKG | In distribution | |
| 50207PKG | In distribution | |
| 50127PKG | In distribution | |
| 50709PKG | In distribution | |
| 50224PKG | In distribution | |
| 50137PKG | In distribution | |
| 50111PKG | In distribution | |
| 50125PKG | In distribution | |
| 50126PKG | In distribution | |
| 50206PKG | In distribution | |
| 50220PKG | In distribution | |
| 50128PKG | In distribution | |
| 50710PKG | In distribution | |
| 50134PKG | In distribution | |
| 50123PKG | In distribution | |
| 50951 | In distribution | |
| 50225PKG | In distribution | |
| 50074PKG | In distribution | |
| 50152 | In distribution | |
| 50205PKG | In distribution | |
| 50204PKG | In distribution | |
| 26570 | In distribution | |
| 50147PKG | In distribution |
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 |
| Fentex | Fentex medical GmbH | 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 |
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.