Brasseler USA
TINISOS6 TIN Comp Isos #6HDL 1P
Who Else Makes It
Concentrated in Zhejiang (31), Jiangsu (27), Guangdong (20). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
Showing 12 of 110. All 110 manufacturers in China registered for Instrument, Manual, Surgical, General Use
Record
| Listed by | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | MDM |
| Device type | Instrument, Manual, Surgical, General Use |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2023-08-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5023261U0 | In distribution | |
| 5023273U0 | In distribution | |
| 5023285U0 | In distribution | |
| 5023260U0 | In distribution | |
| 5023269U0 | In distribution | |
| 5023295U0 | In distribution | |
| 5023300U0 | In distribution | |
| 5023258U0 | In distribution | |
| 5023279U0 | In distribution | |
| 5023281U0 | In distribution | |
| 5023288U0 | In distribution | |
| 5023286U0 | In distribution | |
| 5023282U0 | In distribution | |
| 5023272U0 | In distribution | |
| 5023289U0 | In distribution | |
| 5023292U0 | In distribution | |
| 5023270U0 | In distribution | |
| 5023265U0 | In distribution | |
| 5023278U0 | In distribution | |
| 5023271U0 | In distribution | |
| 5023297U0 | In distribution | |
| 5023268U0 | In distribution | |
| 5023280U0 | In distribution | |
| 5023262U0 | In distribution | |
| 5026522U0 | In distribution | |
| 5023298U0 | In distribution | |
| 5023259U0 | In distribution | |
| 5023266U0 | In distribution | |
| 5023293U0 | In distribution | |
| 5023291U0 | In distribution | |
| 5023299U0 | In distribution | |
| 5023274U0 | In distribution | |
| 5023267U0 | In distribution | |
| 5023277U0 | In distribution | |
| 5023287U0 | In distribution | |
| 5023283U0 | In distribution | |
| 5023264U0 | In distribution | |
| 5023294U0 | In distribution | |
| 5026521U0 | In distribution | |
| 5023276U0 | In distribution | |
| 5023290U0 | In distribution | |
| 5023296U0 | In distribution | |
| 5023284U0 | In distribution | |
| 5023275U0 | In distribution | |
| 5023263U0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 1,686 |
| TSI | Tedan Surgical Innovations, L.L.C. | 1,181 |
| Medfix | Medfix International, LLC | 514 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 446 |
| Fentex | Fentex medical GmbH | 407 |
| Millennium | Avalign Technologies, Inc. | 337 |
| Synergetics | Synergetics USA, Inc. | 312 |
| American Medicals | American Medicals | 298 |
| gSource | Gsource, LLC. | 291 |
| Life Instruments | Life Instrument Corp. | 274 |
| Ambler Surgical | Ambler Surgical, LLC | 272 |
| Instrument, Manual, Surgical, General Use | Karl Storz GmbH & Co. KG | 261 |
Showing 12 of 1,364. All products under Instrument, Manual, Surgical, General Use
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.