Duns Number:071595540
Device Description: VCARE EXTRA LARGE, UTERINE MANIPULATOR, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR
Catalog Number
60-6085-203A
Brand Name
VCARE
Version/Model Number
60-6085-203A
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
5d67dc17-1407-4053-9f7c-3670df515323
Public Version Date
December 07, 2018
Public Version Number
4
DI Record Publish Date
June 10, 2017
Package DI Number
20653405003813
Quantity per Package
8
Contains DI Package
10653405003816
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 |