Catalog Number

-

Brand Name

HandPro 400

Version/Model Number

404

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

e3ed26eb-b5d2-4817-92bd-4c80bcb32e63

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Package DI Number

20810007660510

Quantity per Package

10

Contains DI Package

10810007660513

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case