Reprocessed 3.5mm Aggressive Plus Blade
Catalogue number 375-534-000, listed by Suretek Medical, United States, under Accessories, Arthroscopic. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Shandong (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Zhongshan Saxin Electric Heating Technology Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 27 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
Showing 12 of 14. All 14 manufacturers in China registered for Accessories, Arthroscopic
Record
| Listed by | Suretek Medical, United States |
|---|---|
| FDA product code | NBH |
| Device type | Accessories, Arthroscopic |
| Device class | Class 1 |
| Regulation | 21 CFR 888.1100 |
| Establishment | Reprocessor |
| Premarket notification | Exempt |
| Record published | 2018-12-13 |
| Record revised | 2023-05-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 375-534-000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 1,020 |
| Accessories, Arthroscopic | Smith & Nephew, Inc. | 913 |
| Millennium | Avalign Technologies, Inc. | 335 |
| Surgical Direct | Surgical Direct, Inc. | 312 |
| AED | National Advanced Endoscopy Devices, Inc. | 266 |
| Elmed | Elmed, Inc. | 262 |
| Acufex | Smith & Nephew, Inc. | 260 |
| Razek Equipamentos | Razek Equipamentos Ltda | 235 |
| Sports Med Instruments | Medacta International SA | 175 |
| Conmed | ConMed Corporation | 159 |
| Accessories, Arthroscopic | Richard Wolf Gmbh | 153 |
| Vertebris | Richard Wolf Gmbh | 135 |
Showing 12 of 598. All products under Accessories, Arthroscopic
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.