ARGENCO Au2 - Gold based noble metal - ARGEN CORPORATION, THE

Duns Number:103095543

Device Description: Gold based noble metal

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More Product Details

Catalog Number

121791

Brand Name

ARGENCO Au2

Version/Model Number

121791

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

EJT

Product Code Name

Alloy, gold-based noble metal

Device Record Status

Public Device Record Key

a3fb10eb-c98a-480d-b856-d2a7baf686a8

Public Version Date

March 22, 2022

Public Version Number

1

DI Record Publish Date

March 14, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARGEN CORPORATION, THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 1969