Uterine Injectors are double lumen, slightly curved and designed for single use. It was developed to facilitate diagnostic procedures such as Laparoscopy, Minilaps, Salpingoplasties and…
Uterine Injectors are double lumen, slightly curved and designed for single use. It was developed to facilitate diagnostic procedures such as Laparoscopy, Minilaps, Salpingoplasties and Fertility Examinations. It is a sterile disposable product consisting of plastic tube, connector and other plastic components which meets the USP recommendation for class VI testing.
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (2), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Cannula, Manipulator/Injector, Uterine | Listed by | Panpac Medical Corporation, Taiwan |
| FDA product code | LKF |
| Device type | Cannula, Manipulator/Injector, Uterine |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Record published | 2016-08-15 |
| Record revised | 2022-11-07 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 12, box of 10, box of 25 |
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.