Catalog Number

-

Brand Name

Biogel® Indicator® System

Version/Model Number

31285

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

K071565,K071565,K071565

Product Code

KGO

Product Code Name

Surgeon's gloves

Public Device Record Key

aafef010-8797-454a-af3b-0f5a3f1556c7

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

07323190093021

Quantity per Package

4

Contains DI Package

07323190093014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE