Catalog Number

-

Brand Name

SOLO-TRAK®-KR

Version/Model Number

6208BTK5

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

K965167,K965167

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

608d7e6f-3de9-4f6f-bd30-e17f6d2e076e

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

January 03, 2017

Package DI Number

10681490143094

Quantity per Package

5

Contains DI Package

00681490143097

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK