Catalog Number

455991

Brand Name

Discofix®

Version/Model Number

455991

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

85c6147b-6753-4b01-8597-3733ae5317e4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 21, 2017

Package DI Number

04022495770042

Quantity per Package

2

Contains DI Package

04046964996986

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton