Catalog Number

2N3399

Brand Name

INTERLINK

Version/Model Number

2N3399

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

K925126,K925126

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

9c77fca2-5bb5-414f-9483-2d43610c4433

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

50085412004988

Quantity per Package

200

Contains DI Package

00085412004983

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE