Catalog Number

120220

Brand Name

ARGELITE PF+ (5 dwt)

Version/Model Number

120220

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EJS

Product Code Name

ALLOY, OTHER NOBLE METAL

Public Device Record Key

b9d3b5ef-6dfe-4aff-81cb-8c42c6e65b30

Public Version Date

March 22, 2022

Public Version Number

1

DI Record Publish Date

March 14, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-