Catalog Number

600-NW13

Brand Name

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

Version/Model Number

600-NW13

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

67afa5a4-374f-484e-804b-df58293bb59b

Public Version Date

August 03, 2020

Public Version Number

1

DI Record Publish Date

July 24, 2020

Package DI Number

10814125010038

Quantity per Package

10

Contains DI Package

00814125010031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE