BR Surgical, LLC
WAGENER Ear Hook, with ball tip, size 5, extra delicate, 5 1/2"
2manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | BR Surgical LLC, United States |
|---|---|
| FDA product code | JYL |
| Device type | Hook, Microsurgical Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-03 |
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 |
|---|---|---|
| BR44-19117 | In distribution | |
| BR44-19201 | In distribution | |
| BR44-19301 | In distribution | |
| BR44-19302 | In distribution | |
| BR44-19205 | In distribution | |
| BR44-19202 | In distribution | |
| BR44-19303 | In distribution | |
| BR44-19002 | In distribution | |
| BR44-19306 | In distribution | |
| BR44-19206 | In distribution | |
| BR44-19204 | In distribution | |
| BR44-19001 | In distribution | |
| BR44-19003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 67 |
| Sklar | Sklar Corporation | 59 |
| MicroFrance® | Integra Microfrance SAS | 48 |
| Aesculap | Aesculap AG | 45 |
| V. Mueller | Steris Corporation | 41 |
| Ambler Surgical | Ambler Surgical, LLC | 39 |
| Hook | KLS-Martin L.P. | 35 |
| Boss Instruments | Boss Instruments, Ltd. | 27 |
| Novo Surgical | Novo Surgical, Inc. | 21 |
| Integra® | Integra LifeSciences Production Corporation | 21 |
| Pilling | Teleflex Medical LLC | 17 |
| Avalign | Avalign Technologies, Inc. | 17 |
Showing 12 of 53. All products under Hook, Microsurgical Ear
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.