Catalog Number

-

Brand Name

STERI-SOX SELF SEALING STERILIZATION POUCHES

Version/Model Number

6070560142

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"

-

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

K102158,K102158,K102158

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

de4ae432-781e-4fa9-88ee-6a3e61c9460d

Public Version Date

September 27, 2022

Public Version Number

1

DI Record Publish Date

September 19, 2022

Package DI Number

D89260705601422

Quantity per Package

6000

Contains DI Package

D89260705601421

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE