Catalog Number

6005500045

Brand Name

Getinge Pack Self-Seal Sterilization Pouch 14cm x 28cm

Version/Model Number

6005500045

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

K152669,K152669,K152669

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

5b14ba44-189d-481d-a065-ce9e99593e74

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

20814434020657

Quantity per Package

14

Contains DI Package

10814434020650

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case