Catalog Number

54-64506

Brand Name

DESTINATION

Version/Model Number

54-64506

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

c1d33f9e-cba8-4d3d-a2ed-1402ecc8867e

Public Version Date

December 22, 2021

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

50389701008849

Quantity per Package

10

Contains DI Package

00389701008844

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton