Catalog Number

600-V111

Brand Name

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

Version/Model Number

600-V111

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

90b916d5-b475-4b41-95b5-6511ba988cbe

Public Version Date

August 20, 2020

Public Version Number

1

DI Record Publish Date

August 12, 2020

Package DI Number

20898777001221

Quantity per Package

10

Contains DI Package

00898777001227

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE