Catalog Number

5700639

Brand Name

Henry Schein

Version/Model Number

5700639

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

-

Product Code

KGO

Product Code Name

Surgeon's gloves

Public Device Record Key

d286d7aa-6279-4f2b-9910-cbe49cc70af5

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 23, 2021

Package DI Number

20304040057586

Quantity per Package

5

Contains DI Package

10304040057589

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case