Catalog Number

34102

Brand Name

School Nurse Supply

Version/Model Number

4003

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

7c91b3b5-a40d-4caa-b288-aadd127005f7

Public Version Date

May 13, 2022

Public Version Number

1

DI Record Publish Date

May 05, 2022

Package DI Number

00853927007191

Quantity per Package

1000

Contains DI Package

00850040791006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case