Catalog Number

102-0189

Brand Name

TripleCheck™ Pouch

Version/Model Number

102-0189

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KCT

Product Code Name

Sterilization wrap containers, trays, cassettes & other accessories

Public Device Record Key

ba24f9c8-a9f6-472e-b2a6-f40cccf5001d

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

August 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-