BR Surgical, LLC
PHENOL APPLICATOR, (DUBERSTEN Style) stainless, 0.6mm tynes
25manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (10), Zhejiang (5), Jiangsu (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Dalian Rongbang Medical Healthy Devices Co Ltd | Dalian | Liaoning | Contract manufacturer | 15 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd | Foshan | Guangdong | Contract manufacturer | 11 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Zhejiang Anji Huabu Industrial Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 32 |
| Jiangsu Senwo Medical Technology Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 26 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 21 |
Showing 12 of 25. All 25 manufacturers in China registered for Applicator, Ent
Record
| Listed by | BR Surgical LLC, United States |
|---|---|
| FDA product code | KCJ |
| Device type | Applicator, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5220 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BR44-99610 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novo Surgical | Novo Surgical, Inc. | 10 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 9 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 8 |
| Dryswab | Medical Wire & Equipment Company (Bath), Ltd. | 5 |
| V. Mueller | Carefusion 2200, Inc. | 5 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 5 |
| Aesculap | Aesculap AG | 4 |
| Integra® | Integra LifeSciences Production Corporation | 4 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 4 |
| NeilMed Sinus Rinse | Neilmed Pharmaceuticals, Inc. | 3 |
| Applicator, Ent | Summit Medical LLC | 3 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 3 |
Showing 12 of 40. All products under Applicator, Ent
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.