Catalog Number

131764

Brand Name

ArgenZ HT+ 98x30 ML OM1B

Version/Model Number

131764

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

K190079

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Public Device Record Key

1d43bb5f-6cc2-474d-b226-885c51df7cb1

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

-