BR Surgical, LLC
JACKSON Trachea Hook, sharp, 6"
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Zhejiang (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 |
| Hangzhou Alline Plastic Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 16 |
Record
| Listed by | BR Surgical LLC, United States |
|---|---|
| FDA product code | KCH |
| Device type | Hook, Tracheal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-10 |
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 |
|---|---|---|
| BR54-11615 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 18 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 9 |
| Sklar® | Sklar Corporation | 9 |
| Boss Instruments | Boss Instruments, Ltd. | 8 |
| Millennium | Avalign Technologies, Inc. | 7 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 7 |
| Avalign | Avalign Technologies, Inc. | 7 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 5 |
| Aesculap | Aesculap AG | 5 |
| Symmetry Cottle | Aspen Surgical Products, Inc. | 4 |
| V. Mueller | Steris Corporation | 4 |
| Pilling | Teleflex Medical LLC | 4 |
Showing 12 of 30. All products under Hook, Tracheal
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.