Norsen Debrider, Sterile
Catalogue number AB137, listed by BEL-MED, Inc, United States, under Brush, Dermabrasion, Manual. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (12), Jiangsu (3), Hebei (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd | Foshan | Guangdong | Contract manufacturer | 11 |
| Foshan City Mingshang Beauty AND Hair Equipment Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 1 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Huanghua DK Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 37 |
| Guangdong Xinuo Personal Care Products Co., Ltd. | Yunfu | Guangdong | Manufacturer | 33 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Hangzhou Zhongzhi Industry Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
Showing 12 of 21. All 21 manufacturers in China registered for Brush, Dermabrasion, Manual
Record
| Listed by | BEL-MED, Inc, United States |
|---|---|
| FDA product code | GED |
| Device type | Brush, Dermabrasion, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-05-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 40, box of 30, box of 50, box of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AB137 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 9 |
| Dermal Cooling System | R2 Technologies, Inc. | 2 |
| Cook | Cook Incorporated | 1 |
| Medline | Medline Industries, Inc. | 1 |
| Buxton BioMedical | Buxton Biomedical, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K821801 | 1982-07-28 |
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.