Catalog Number

-

Brand Name

Biogel® Diagnostic

Version/Model Number

30380

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

K971514,K971514,K971514

Product Code

LYY

Product Code Name

Latex patient examination glove

Public Device Record Key

a1439ae2-ba9c-460a-9e8d-4b33acadc9a0

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

05060097937219

Quantity per Package

6

Contains DI Package

05060097937134

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE