LiNA OperaScope™ Tubing & Drape Kit
Tubing & drape for hysteroscopy
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Anhui.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
Record
| Listed by | LiNA Medical AG, Switzerland |
|---|---|
| FDA product code | NVT |
| Device type | Tubing And Tubing/Filter Fits |
| Device class | Class 1 |
| Regulation | 21 CFR 884.1700 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-08-03 |
| Record revised | 2024-09-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 6, pack of 6 |
| Distribution end date | 2020-09-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OP-TDK-6 | Withdrawn | |
| OP-TDK-6 | Withdrawn | |
| OP-TDK-6 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tubing And Tubing/Filter Fits | Karl Storz GmbH & Co. KG | 8 |
| Custom Medical Specialties, Inc. | Custom Assemblies, Inc. | 4 |
| Rocket | Rocket Medical PLC | 3 |
| ThermaClear | Stryker GmbH | 1 |
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.