Catalog Number

61301606742

Brand Name

Getinge Pack Tyvek Pouch

Version/Model Number

GUTP2538

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

K160595,K160595,K160595

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

5bccde45-fe29-4828-8a35-f8ea98af6ecc

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

October 01, 2017

Package DI Number

10850144008182

Quantity per Package

3

Contains DI Package

00850144008185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case