Catalog Number

Model190

Brand Name

Freeguard

Version/Model Number

Model190

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"

Yes

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

-

Product Code

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

a355d367-e4fc-468b-ae47-0ca08076de75

Public Version Date

February 21, 2019

Public Version Number

2

DI Record Publish Date

March 16, 2018

Package DI Number

08054301891401

Quantity per Package

5

Contains DI Package

08054301890664

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-