Duns Number:257261032
Device Description: This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless steel tenacul This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless steel tenaculum. The Valtchev Tenaculum is used to hold the VUM-6 uterine mobilizer in place when the cannulas 15A or 16A are used for injection of either dye or an X-ray contrast medium. This tenaculum 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
VT
Brand Name
Valtchev Uterine Mobilizer
Version/Model Number
VT
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
157b305f-7160-4d27-a804-a4118936ba7f
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 |