Catalog Number

VIVCF02

Brand Name

COUPLING FLUID

Version/Model Number

VIVCF02

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

K082962,K082962

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

59a95c55-3943-4d4e-8684-04c24d43db1a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 03, 2016

Package DI Number

10850794007078

Quantity per Package

6

Contains DI Package

00850794007071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case