Catalog Number

1273172

Brand Name

CleanCut™ Extended Use Diamond FG US 285.5C

Version/Model Number

1273172

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

DZP

Product Code Name

INSTRUMENT, DIAMOND, DENTAL

Public Device Record Key

8656fb5f-ed89-4405-99d9-5d13d39e826c

Public Version Date

July 22, 2021

Public Version Number

1

DI Record Publish Date

July 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-