SpyGlass DS
2 catalogue numbers from M0054665ZR0, listed by Boston Scientific Corporation, United States, under Led Light Source. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Dongguan Miqiang Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Shenzhen Yiguangnian Innovation Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 13 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Hunan Endoso Life Technology Co., Ltd. | Xiangtan | Hunan | Manufacturer | 7 |
| Shenzhen Sophway Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | NTN |
| Device type | Led Light Source |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2019-02-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M0054665ZR0 | In distribution | |
| M00546650 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Led Light Source | Schölly Fiberoptic GmbH | 12 |
| Lucea LED® | Maquet Gmbh | 9 |
| Endolight | Richard Wolf Gmbh | 7 |
| ILO | ILO Electronic Gmbh | 7 |
| BR Surgical, LLC | BR Surgical LLC | 7 |
| Led Light Source | Karl Storz GmbH & Co. KG | 6 |
| Everlux Light Source | Ecleris SRL | 5 |
| eLUMA | ConMed Corporation | 5 |
| Led Light Source | Maquet Gmbh | 4 |
| Gimmi | Gimmi Gmbh | 4 |
| Comeg Medical | Sopro | 4 |
| Led Light Source | Richard Wolf Gmbh | 4 |
Showing 12 of 42. All products under Led Light Source
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.