Duns Number:257261032
Device Description: This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless steel obturat This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless steel obturator having a length of 45 mm and shaft thickness of 3 mm. The pin on the obturator must slip into the notch of the head of the VUM-6 base instrument. The obturator has no stand alone functionality and is either sold as part of the VUM-6 complete set or as a separate replacement part.
Catalog Number
17
Brand Name
Valtchev Uterine Mobilizer
Version/Model Number
17
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LKF
Product Code Name
Cannula, Manipulator/Injector, Uterine
Public Device Record Key
de85a0d6-4802-4ac2-9006-d320006f7ca3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |