Duns Number:257261032
Device Description: This is the large locking screw for the VUM-6 and is part of the VUM-6 when sold as a comp This is the large locking screw for the VUM-6 and is part of the VUM-6 when sold as a complete unit. The locking screw has no stand alone functionality and is to be used in conjunction with the VUM-6 uterine mobilizer. This is a replacement part that can be ordered separately.
Catalog Number
8
Brand Name
Valtchev Uterine Mobilizer
Version/Model Number
8
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
d342727a-bf76-4e0b-a992-ae08c1ae2e45
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 |