Instrapac
Instrapac Wooden Tongue Depressors X 5,000 (50 boxes of 100)
100manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (24), Jiangsu (20), Shanghai (13). 9 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 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Across Medical Disposables Co., Ltd. | Anqing | Anhui | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
Showing 12 of 100. All 100 manufacturers in China registered for Depressor, Tongue, Non-Surgical
Record
| Listed by | Robinson Healthcare Limited, United Kingdom |
|---|---|
| FDA product code | FMA |
| Device type | Depressor, Tongue, Non-Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6230 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-09-11 |
| Record revised | 2026-02-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry and keep out of direct sunlight |
| Packaging | Box of 5000 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8360 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aesculap | Aesculap AG | 21 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 21 |
| Puritan | Puritan Medical Products Company LLC | 12 |
| Tongue-Away Sheild | TP Orthodontics, Inc. | 8 |
| AMD-Ritmed Solon | AMD Medicom Inc. | 6 |
| McKesson | Mckesson Medical-Surgical Inc. | 6 |
| HCS | Dyad Medical Sourcing, LLC | 5 |
| JMU | JMU Dental, Inc | 5 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| Symmetry Wieder | Aspen Surgical Products, Inc. | 4 |
| Dealmed | Dealmed Medical Supplies LLC | 4 |
| HCS | Concordance Healthcare Solutions LLC | 4 |
Showing 12 of 51. All products under Depressor, Tongue, Non-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.