DeRoyal
St. Curved Hemostat with Gauze
12manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (3), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 37 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| H&K International Trade Limited (China) | Jinhua | Zhejiang | Contract manufacturer | 29 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | HRQ |
| Device type | Hemostat |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-06-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31-258 | In distribution | |
| 32-350 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 429 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 249 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 231 |
| Aesculap | Aesculap AG | 183 |
| Boss Instruments | Boss Instruments, Ltd. | 182 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 164 |
| BR Surgical, LLC | BR Surgical LLC | 123 |
| Hayden Medical | Hayden Medical Inc | 93 |
| Surgipros | Surgipros LLC | 71 |
| Pilling | Teleflex Medical LLC | 70 |
| V. Mueller | Steris Corporation | 41 |
| Cardinal Health | Cardinal Health 200, LLC | 39 |
Showing 12 of 92. All products under Hemostat
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.