Avalign
McGee Footplate Anterior Pick, angled up, OL160mm (6 1/4")
10manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (2), Shanghai (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 |
| Huizhou Gold Rose Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 19 |
| Global Best WAY Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Hong YU Kang Technology (Guangdong) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Omedic Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Repacker / relabeller | 8 |
| Shenzhen Jiding Electronic Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Shenzhen Alex Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Heifeng Zhizao(Shenzhen)Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Ningbo Yinzhou Keyvan Household Products Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | JYT |
| Device type | Pick, Microsurgical Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-11-03 |
| Record revised | 2023-07-06 (version 2) |
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 |
|---|---|---|
| VM101-4437 | In distribution | |
| VM101-4712 | In distribution | |
| VM101-4620 | In distribution | |
| VM101-4713 | In distribution | |
| VM101-4442 | In distribution | |
| VM101-4436 | In distribution | |
| VM101-4631 | In distribution | |
| VM101-4447 | In distribution | |
| VM101-4448 | In distribution | |
| VM101-4434 | In distribution | |
| VM101-4438 | In distribution | |
| VM10145432 | In distribution | |
| VM101-4444 | In distribution | |
| VM101-4222 | In distribution | |
| VM101-4439 | In distribution | |
| VM101-4110 | In distribution | |
| VM101-4517 | In distribution | |
| VM101-4443 | In distribution | |
| VM101-4165 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fentex | Fentex medical GmbH | 116 |
| BR Surgical, LLC | BR Surgical LLC | 52 |
| Ambler Surgical | Ambler Surgical, LLC | 51 |
| Boss Instruments | Boss Instruments, Ltd. | 38 |
| Integra® | Integra LifeSciences Production Corporation | 35 |
| Bear | Bear-ENT, LLC | 34 |
| V. Mueller | Steris Corporation | 33 |
| Millennium | Avalign Technologies, Inc. | 32 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 31 |
| Aesculap | Aesculap AG | 29 |
| Inka | The Trustee for Kaiser Family Trust | 27 |
| mytaMed | Mytamed, Inc. | 27 |
Showing 12 of 49. All products under Pick, 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.