Duns Number:071595540
Device Description: VCARE DX UTERINE MANIPULATOR/INJECTOR CANNULA
Catalog Number
60-6080-000A
Brand Name
VCARE DX
Version/Model Number
60-6080-000A
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
K142716,K142716,K142716
Product Code
LKF
Product Code Name
Cannula, manipulator/injector, uterine
Public Device Record Key
506a1e2b-fa57-4f18-ba5b-c4ef63d2a129
Public Version Date
December 07, 2018
Public Version Number
4
DI Record Publish Date
June 12, 2017
Package DI Number
20653405003714
Quantity per Package
8
Contains DI Package
10653405003717
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |