Bausch + Lomb
N1685 D7 PCK Mgee DN90DG (Disc)
10manufacturers in China registered for this device type
31catalogue 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 | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | JYT |
| Device type | Pick, Microsurgical Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-08-04 |
| Record revised | 2025-09-10 (version 3) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N1705 80 | In distribution | |
| N1685 D 5 | In distribution | |
| N1705 82F | In distribution | |
| N1685 D10 | In distribution | |
| N1691 12 | In distribution | |
| N1705 82MS | In distribution | |
| N1699 J | In distribution | |
| N1705 83JS | In distribution | |
| N1685 J12 | In distribution | |
| N1692 9 | In distribution | |
| N1705 82M | In distribution | |
| N1691 36 | In distribution | |
| N1685 J 8 | In distribution | |
| N1705 83A | In distribution | |
| N1692 17 | In distribution | |
| N1705 79H | In distribution | |
| N1707 10 | In distribution | |
| N1705 82S | In distribution | |
| N1685 D 4 | In distribution | |
| N1691 18 | In distribution | |
| N1692 16 | In distribution | |
| SP7-64085 | In distribution | |
| SP7-68756 | In distribution | |
| N1691 10 | In distribution | |
| N1705 83C | In distribution | |
| N1705 81 | In distribution | |
| N1705 79 | In distribution | |
| N1705 83B | In distribution | |
| N1705 83J | In distribution | |
| N1705 21 | In distribution | |
| SP7-64084 | 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 |
| Aesculap | Aesculap AG | 29 |
| Inka | The Trustee for Kaiser Family Trust | 27 |
| mytaMed | Mytamed, Inc. | 27 |
| Bear | Mytamed, Inc. | 25 |
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.