Russel-Davis Tongue Depressor
size 5, with central channel outlet left side, 46x107 mm
10manufacturers in China registered for this device type
11catalogue 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 | Spiggle & Theis Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | KBL |
| Device type | Depressor, Metal Tongue, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40-316-02 | In distribution | |
| 40-318-05 | In distribution | |
| 40-315-04 | In distribution | |
| 40-315-05 | In distribution | |
| 40-315-03 | In distribution | |
| 40-316-04 | In distribution | |
| 40-315-01 | In distribution | |
| 40-316-03 | In distribution | |
| 40-316-01 | In distribution | |
| 40-315-02 | In distribution | |
| 40-316-05 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar | Sklar Corporation | 58 |
| MicroFrance® | Integra Microfrance SAS | 18 |
| Davis-Boyle tongue depressor | Spiggle & Theis Medizintechnik Gmbh | 14 |
| 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.