Duns Number:257261032
Device Description: This item is the VUM-6 Tube for Dye Injection which is an integral part of the Valtchev Ut This item is the VUM-6 Tube for Dye Injection which is an integral part of the Valtchev Uterine Mobilizer, Model VUM-6. The tube has no stand alone functionality and is part of the VUM-6 device. This is a replacement part that can be ordered separately if needed.
Catalog Number
9A
Brand Name
Valtchev Uterine Mobilizer
Version/Model Number
9A
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
ba62ac67-6842-4651-b2e0-173aebac606a
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 |