The Uterine manipulator/Injector both a Uterine Manipulator and a Uterine Injector with application in Diagnostic Laparoscopy, Minilaparotomy, Fertility Examinations and salpingoplastics.
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 Uterine Manipulator / Injector 4,5mm | Listed by | Purple Surgical International Limited, United Kingdom |
| FDA product code | LKF |
| Device type | Cannula, Manipulator/Injector, Uterine |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-17 |
| Record revised | 2018-03-29 (version 2) |
Specifications
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 |
| Packaging | Shipping carton of 40, shelf box of 10 |
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.