Catalog Number

456003

Brand Name

Discofix®

Version/Model Number

456003

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

-

Product Code

KGZ

Product Code Name

ACCESSORIES, CATHETER

Public Device Record Key

f61a3a12-f0c2-40a7-9d71-2ded981a5733

Public Version Date

September 21, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

04022495770059

Quantity per Package

2

Contains DI Package

04046964183577

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton