Catalog Number

-

Brand Name

Inrad

Version/Model Number

50019

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

K812973,K812973

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

ab6cdc12-0b64-4b62-885f-41164d1197e3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 01, 2016

Package DI Number

10817295020609

Quantity per Package

20

Contains DI Package

00817295020602

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton