Catalog Number

-

Brand Name

TRIPOD Heart Stabilizer Med Mtl FasTract

Version/Model Number

STB-30C2S

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MWS

Product Code Name

Stabilizer,Heart

Public Device Record Key

eeeaba70-15d5-45c3-ba78-96d1bc7cbcb4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-