Manus Medical, LLC
Scatpad, Dbl. Tape, 12.5" x 16.5"
5manufacturers in China registered for this device type
1catalogue number
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 | Manus Medical, LLC, United States |
|---|---|
| FDA product code | IWX |
| Device type | Barrier, Control Panel, X-Ray, Movable |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SEPA 402-DT-1 | 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 |
| Britedent | Bright Supply Inc | 4 |
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.