Catalog Number

V3GISSR

Brand Name

V-Set

Version/Model Number

V3 GISS

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K900336,K900336,K900336,K900336

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

640caf43-828c-40e9-a2da-a2048bd1cb53

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

9350902000082

Quantity per Package

600

Contains DI Package

09350902000051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer carton - HEE