Catalog Number

61301606732

Brand Name

Getinge Pack Tyvek Roll

Version/Model Number

GUTY0530

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

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

baa3c9aa-cfbe-45ea-9d01-21ca593f1134

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

September 10, 2017

Package DI Number

10850144008083

Quantity per Package

12

Contains DI Package

00850144008086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case