Monolith Prophy Paste Xtra COARSE "Spearmint" Cup - PRISMAN INC.

Duns Number:117569946

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More Product Details

Catalog Number

-

Brand Name

Monolith Prophy Paste Xtra COARSE "Spearmint" Cup

Version/Model Number

M506

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

35271e52-ce49-4acd-8d18-d444b1d3eedb

Public Version Date

October 18, 2021

Public Version Number

1

DI Record Publish Date

October 10, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRISMAN INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29