Catalog Number

GS5-1D

Brand Name

3M™ Steri-Vac™

Version/Model Number

GS5-1D

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K142034

Product Code

FLF

Product Code Name

Sterilizer, ethylene-oxide gas

Public Device Record Key

70b377a9-73da-4936-8db7-bbb62306668f

Public Version Date

October 30, 2020

Public Version Number

1

DI Record Publish Date

October 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-