dental diamond bur - Dental Diamond Bur - STRAUSS & CO - INDUSTRIAL DIAMONDS LTD

Duns Number:600028195

Device Description: Dental Diamond Bur

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More Product Details

Catalog Number

Z33RD181

Brand Name

dental diamond bur

Version/Model Number

Z33RD181

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

-

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

DZP

Product Code Name

Instrument, Diamond, Dental

Device Record Status

Public Device Record Key

97de6e45-5398-4ad6-8558-7f3f9f2862b5

Public Version Date

March 23, 2020

Public Version Number

3

DI Record Publish Date

February 11, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRAUSS & CO - INDUSTRIAL DIAMONDS LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 608