Catalog Number

61301606735

Brand Name

Getinge Pack Tyvek Roll

Version/Model Number

GUTY2030

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

873d7e2b-3086-4010-ba92-2e21b3a705af

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

September 25, 2017

Package DI Number

10850144008113

Quantity per Package

4

Contains DI Package

00850144008116

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case