Select Assorted Medium Prophy Paste (200) - BURKHART DENTAL SUPPLY CO., THE

Duns Number:027532357

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More Product Details

Catalog Number

-

Brand Name

Select Assorted Medium Prophy Paste (200)

Version/Model Number

72721454

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"

Yes

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

b2865a7f-38f0-467d-a2dd-57579b80ee64

Public Version Date

April 26, 2019

Public Version Number

1

DI Record Publish Date

April 18, 2019

Additional Identifiers

Package DI Number

00815878021930

Quantity per Package

200

Contains DI Package

00815878021923

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"BURKHART DENTAL SUPPLY CO., THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 214
2 A medical device with a moderate to high risk that requires special controls. 43