Duns Number:753476779
Device Description: Uterine Manipulator
Catalog Number
UM-TV
Brand Name
ManipulatOR
Version/Model Number
UM-TV
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
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
1845dc43-5913-4416-831e-5cfe06f611ff
Public Version Date
December 07, 2018
Public Version Number
3
DI Record Publish Date
November 09, 2016
Package DI Number
09349967000021
Quantity per Package
6
Contains DI Package
09349967000014
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |