Catalog Number

6005500044

Brand Name

Getinge Pack Self-Seal Sterilization Pouch 13cm x 38cm

Version/Model Number

6005500044

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2016

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

K152669,K152669,K152669

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

3a1f8849-e913-45d0-bd13-06b2d791aeca

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

20814434020640

Quantity per Package

6

Contains DI Package

10814434020643

Package Discontinue Date

September 23, 2016

Package Status

Not in Commercial Distribution

Package Type

Case