Catalog Number

-

Brand Name

Sterilization Pouches

Version/Model Number

4461

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

-

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

9595e274-1a8e-483c-9227-b87ca7c0edb3

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

00616784446134

Quantity per Package

30

Contains DI Package

00616784446127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-