Catalog Number

-

Brand Name

Fortis

Version/Model Number

504-SP

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

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

f9a8b203-94be-4cbf-acc6-2c99345db647

Public Version Date

September 12, 2022

Public Version Number

2

DI Record Publish Date

September 01, 2022

Package DI Number

20810007660619

Quantity per Package

100

Contains DI Package

10810007660612

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case