Catalog Number

34101

Brand Name

School Nurse Supply

Version/Model Number

4002

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

LYZ

Product Code Name

Vinyl Patient Examination Glove

Public Device Record Key

5a4410d3-d6a9-4b22-9c30-9e9df2132f50

Public Version Date

May 13, 2022

Public Version Number

1

DI Record Publish Date

May 05, 2022

Package DI Number

00853927007993

Quantity per Package

1000

Contains DI Package

00853927007986

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case