Sterile Sheath for Convivo
Catalogue number 302732-0530-000, listed by Carl Zeiss Meditec Inc, United States, under Confocal Optical Imaging. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (1), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Wuxi Hisky Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Carl Zeiss Meditec Inc, United States |
|---|---|
| FDA product code | OWN |
| Device type | Confocal Optical Imaging |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K181116 |
| Record published | 2019-12-13 |
| Record revised | 2023-09-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 302732-0530-000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VS3-IR | Visionsense, Ltd. | 22 |
| Confocal Microprobe Imaging System | Wuxi Hisky Medical Technologies Co., Ltd. | 16 |
| Confocal Optical Imaging | Karl Storz GmbH & Co. KG | 13 |
| Hopkins | Karl Storz GmbH & Co. KG | 4 |
| AIM (Advanced Imaging Modality) | Stryker GmbH | 4 |
| VS3-NE | Visionsense, Ltd. | 3 |
| Open Field Fluorescence Imaging Head | Guangdong Optomedic Technologies, Inc. | 3 |
| Cellvizio® 100 series (488nm) | Mauna KEA Technologies | 3 |
| Photonvue | Fluoptics SAS | 2 |
| VS3 Iridium | Visionsense, Ltd. | 2 |
| SafeLight | Stryker GmbH | 2 |
| 1588 AIM | Stryker GmbH | 2 |
Showing 12 of 74. All products under Confocal Optical Imaging
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.