Bear
Day Ear Hook, 90 Degree Fine Tip, Medium (2.0mm)
2manufacturers in China registered for this device type
17catalogue 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 | Bear-ENT, 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-06-12 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6.16.01 | In distribution | |
| 6.17.05 | In distribution | |
| 6.16.02 | In distribution | |
| 6.18.01 | In distribution | |
| 6.17.01 | In distribution | |
| 6.16.03 | In distribution | |
| 6.15.01 | In distribution | |
| 6.15.05 | In distribution | |
| 6.17.02 | In distribution | |
| 6.15.02 | In distribution | |
| 6.15.10 | In distribution | |
| 6.15.06 | In distribution | |
| 6.17.03 | In distribution | |
| 6.15.08 | In distribution | |
| 6.15.09 | In distribution | |
| 6.17.04 | In distribution | |
| 6.15.03 | 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.