Catalog Number

-

Brand Name

Biogel® PI UltraTouch® S Indicator® System

Version/Model Number

45965

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190077,K190077,K190077

Product Code

KGO

Product Code Name

Surgeon's gloves

Public Device Record Key

e2e53a65-bdc5-4474-93ad-7c6d12aac6be

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

07323190240111

Quantity per Package

4

Contains DI Package

07323190240128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE