VCARE - VCARE MEDIUM, UTERINE MANIPULATOR, - Conmed Corporation

Duns Number:071595540

Device Description: VCARE MEDIUM, UTERINE MANIPULATOR, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR

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More Product Details

Catalog Number

60-6085-201A

Brand Name

VCARE

Version/Model Number

60-6085-201A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LKF

Product Code Name

Cannula, manipulator/injector, uterine

Device Record Status

Public Device Record Key

f6a9c60f-56ea-4081-a2e7-3a270f13da65

Public Version Date

December 07, 2018

Public Version Number

4

DI Record Publish Date

June 10, 2017

Additional Identifiers

Package DI Number

20653405003790

Quantity per Package

8

Contains DI Package

10653405003793

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"CONMED CORPORATION" Characteristics
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