Catalog Number

61301606745

Brand Name

Getinge Pack Sterilization Roll

Version/Model Number

GUFL0530

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

K162362,K162362

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

4fad58d2-6796-4fc8-9dd2-85c410bde315

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

December 17, 2017

Package DI Number

10850144008212

Quantity per Package

12

Contains DI Package

00850144008215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case