Catalog Number

SGL85075

Brand Name

HALYARD

Version/Model Number

SGL85075

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)

Yes

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

9309c5a8-534f-40db-9854-bba31a71d027

Public Version Date

March 18, 2022

Public Version Number

1

DI Record Publish Date

March 10, 2022

Package DI Number

20680651483038

Quantity per Package

50

Contains DI Package

10680651483031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser