Catalog Number

406704

Brand Name

Fast-Cath™

Version/Model Number

406704

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)

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

b7886f74-7b73-4206-9cf8-3ec1a7695ec9

Public Version Date

September 21, 2020

Public Version Number

5

DI Record Publish Date

April 30, 2015

Package DI Number

15414734216972

Quantity per Package

10

Contains DI Package

05414734216975

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-