AMD-Ritmed Solon
AMD-RITMED SOLON STANDARD TONGUE DEPRESSORS 6 inch
100manufacturers in China registered for this device type
6catalogue numbers in this listing
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 | AMD Medicom Inc., Canada |
|---|---|
| FDA product code | FMA |
| Device type | Depressor, Tongue, Non-Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6230 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-01-16 |
| Record revised | 2023-11-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment humidity up to 80 % RH; Special storage condition: Room temperature |
| Packaging | Outer case of 10, inner box of 250, pack of 100, case of 10, outer case of 12 |
| Distribution end date | 2023-11-08 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 50000 | 5.5 inch | 500 | In distribution |
| 58000 | Withdrawn | ||
| 52000 | 6 inch | 500 | Withdrawn |
| 55600 | 6 inch | Withdrawn | |
| 52100 | 6 inch | 100 | Withdrawn |
| 51100 | 1,000 | Withdrawn |
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 |
| 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 |
| Wieder Tongue Depressor | Sontec Instruments, Inc. | 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.