Britedent
Barrier Film Black
5manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (2), Tianjin (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tianjin Kanghuajianye Medical Materials Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 1 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Bgss Company Asia Limited | Zhabei | Shanghai | Contract manufacturer | 25 |
| Medipack Medical Packaging MFG. Co. | Dongguan | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Bright Supply Inc, United States |
|---|---|
| FDA product code | IWX |
| Device type | Barrier, Control Panel, X-Ray, Movable |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2020-11-26 |
| Record revised | 2024-09-11 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Packaging | Box of 8 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BSI-0101 | In distribution | |
| BSI-0105 | In distribution | |
| BSI-0102 | In distribution | |
| BSI-0103 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aadco | Aadco Medical, Inc. | 214 |
| Hercules | Aadco Medical, Inc. | 126 |
| WD | Mavig Gmbh | 63 |
| MRI-Safe | Aadco Medical, Inc. | 46 |
| Image Diagnostics, Inc | Image Diagnostics, Inc. | 21 |
| ScatPad | Cardio Medical Products, Inc. | 18 |
| Techno-Aide | Techno-Aide, Inc. | 15 |
| Kenex | Kenex (Electro-Medical) Ltd. | 15 |
| MasterPeace | Texray AB | 14 |
| ErgoLite | Aadco Medical, Inc. | 8 |
| PlastCare | Proguard Health Inc. | 5 |
| Dental City | ICP, Inc. | 3 |
Showing 12 of 20. All products under Barrier, Control Panel, X-Ray, Movable
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.