Catalog Number

TMC150

Brand Name

TRACKER-17

Version/Model Number

M003TMC1500

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 15, 2017

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Public Device Record Key

15b20464-2b8b-4791-991a-0f1dce9f1621

Public Version Date

October 23, 2020

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-