Catalog Number

-

Brand Name

SOLO-TRAK®-KR

Version/Model Number

6210BTK5S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 23, 2018

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

K965167,K965167

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

e524621d-8ebc-4b91-aaf3-8a09e2ea52dd

Public Version Date

June 07, 2019

Public Version Number

5

DI Record Publish Date

January 03, 2017

Package DI Number

10721902577304

Quantity per Package

5

Contains DI Package

00721902577307

Package Discontinue Date

May 23, 2018

Package Status

Not in Commercial Distribution

Package Type

PK