Catalog Number

0912197000

Brand Name

NA

Version/Model Number

0912197000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 22, 2016

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

-

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

75b48e9b-256f-4db3-97a8-3ef29c967f49

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

January 29, 2016

Package DI Number

37613327115933

Quantity per Package

20

Contains DI Package

07613327115932

Package Discontinue Date

August 22, 2016

Package Status

Not in Commercial Distribution

Package Type

pack