MARK3 - Prophy Paste Medium Mint 200/bx. - MARK3® - CARGUS INTERNATIONAL, INC

Duns Number:096191093

Device Description: Prophy Paste Medium Mint 200/bx. - MARK3®

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More Product Details

Catalog Number

-

Brand Name

MARK3

Version/Model Number

1544

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)

-

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

EJR

Product Code Name

Agent, Polishing, Abrasive, Oral Cavity

Device Record Status

Public Device Record Key

15ca336f-10c2-4e19-9bc7-12c1c9b5f374

Public Version Date

October 12, 2021

Public Version Number

1

DI Record Publish Date

October 04, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARGUS INTERNATIONAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 96
2 A medical device with a moderate to high risk that requires special controls. 93
U Unclassified 1