Cotton Bite Block
MECTA ECT Cotton Bite Blocks Size Medium
4manufacturers in China registered for this device type
2catalogue 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 | Sigmastim Domestic LLC, United States |
|---|---|
| FDA product code | JXL |
| Device type | Block, Bite |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5070 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K201309 |
| Record published | 2025-01-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9391-0003 M | In distribution | |
| 9391-0003 L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 3 |
| 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.