Catalog Number

600-V112-BX

Brand Name

Professional Medical Surgical Supply, Inc. d / b / a International Direct

Version/Model Number

600-V112-BX

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LYZ

Product Code Name

Vinyl patient examination glove

Public Device Record Key

78a19478-ed4c-43e0-814f-b40866959d73

Public Version Date

August 13, 2020

Public Version Number

2

DI Record Publish Date

July 24, 2020

Package DI Number

10814125010885

Quantity per Package

10

Contains DI Package

00814125010888

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE