Hudson RCI
Disposable Bite Stick Bite Block/Tongue Depressor
4manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Yangdong Honghai Plastics Production Company | Yangjiang | Guangdong | Contract manufacturer | 3 |
| Yangjiang Junchang Trading Co., Ltd. | Yangjiang | Guangdong | Exporter | 3 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | JXL |
| Device type | Block, Bite |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K830090 |
| Record published | 2018-09-15 |
| Record revised | 2025-01-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Case of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN041777 | In distribution | |
| IPN041777 | In distribution | |
| IPN049862 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cotton Bite Block | Sigmastim Domestic LLC | 2 |
| MouthGuard | Somatics, LLC | 2 |
| Ventil-A Oral Protector | Somatics, LLC | 1 |
| Pati | Neurovice, L.L.C. | 1 |
| Grafco | GF Health Products, Inc | 1 |
| Ethox Medical | Ethox Corp. | 1 |
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.