Duns Number:239403863
Device Description: The Uterine manipulator/Injector both a Uterine Manipulator and a Uterine Injector with ap The Uterine manipulator/Injector both a Uterine Manipulator and a Uterine Injector with application in Diagnostic Laparoscopy, Minilaparotomy, Fertility Examinations and salpingoplastics.
Catalog Number
PS3111
Brand Name
Uterine Manipulator / Injector 4,5mm
Version/Model Number
PS3111
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
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
4e8a3d47-514f-4027-a04c-3b787e44b245
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2016
Package DI Number
55051223000605
Quantity per Package
40
Contains DI Package
35051223000601
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipping carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 20 |
2 | A medical device with a moderate to high risk that requires special controls. | 128 |