MicroFrance®
MicroFrance® Davis-Boyle mouth gag blade 60 x 25 mm, with suction tube, size 2
10manufacturers in China registered for this device type
18catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Shandong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Little Doctor Electronic(Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 17 |
| Shanghai FLY Medical Devices Co., Ltd. | Minhang District | Shanghai | Manufacturer | 15 |
Record
| Listed by | Integra Microfrance SAS, France |
|---|---|
| FDA product code | KBL |
| Device type | Depressor, Metal Tongue, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-12 |
| Record revised | 2023-05-11 (version 6) |
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, manufacturing date |
| Distribution end date | 2019-09-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MCR3A | In distribution | |
| 7802S-2 | In distribution | |
| 7802S-5 | In distribution | |
| MCR2A | In distribution | |
| MCL206A5 | In distribution | |
| MCL206A4 | In distribution | |
| MCL206A3 | In distribution | |
| 7797-2 | In distribution | |
| 7857 | In distribution | |
| 7802S-4 | In distribution | |
| 7797-1 | In distribution | |
| MCL206A1 | In distribution | |
| 7857 | In distribution | |
| 7800MF | In distribution | |
| MCL206A2 | In distribution | |
| 7802S-3 | In distribution | |
| 7802S-1 | In distribution | |
| 7803SAT-3 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar | Sklar Corporation | 58 |
| Davis-Boyle tongue depressor | Spiggle & Theis Medizintechnik Gmbh | 14 |
| Russel-Davis tongue depressor | Spiggle & Theis Medizintechnik Gmbh | 11 |
| Aesculap | Aesculap AG | 10 |
| Millennium | Avalign Technologies, Inc. | 9 |
| Ambler Surgical | Ambler Surgical, LLC | 8 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 7 |
| BR Surgical, LLC | BR Surgical LLC | 6 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 6 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 5 |
| Tongue depressor, Wuerzburg type | Spiggle & Theis Medizintechnik Gmbh | 5 |
| Pilling | Teleflex Medical LLC | 5 |
Showing 12 of 48. All products under Depressor, Metal Tongue, 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.