Catalog Number

12335

Brand Name

Tyvek Self Seal Pouch

Version/Model Number

12335

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141693,K112087,K103210,K103210,K112087,K141693,K112087,K141693,K103210

Product Code

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

eb686c2a-9716-4550-a3cd-3a269535aa1a

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

20705037015747

Quantity per Package

2

Contains DI Package

10705037015740

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case