Catalog Number

-

Brand Name

Tyvek™ Self-Seal Pouch

Version/Model Number

TSP-180

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K123162,K123162,K123162

Product Code

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

3fe18864-b025-45a9-b1b8-1037ecf00241

Public Version Date

May 11, 2022

Public Version Number

1

DI Record Publish Date

May 03, 2022

Package DI Number

50732224009006

Quantity per Package

10

Contains DI Package

10732224009008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-