FG diamond - FG diamond coarse - DFS - DIAMON GmbH

Duns Number:316179456

Device Description: FG diamond coarse

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More Product Details

Catalog Number

-

Brand Name

FG diamond

Version/Model Number

536985

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

DZP

Product Code Name

INSTRUMENT, DIAMOND, DENTAL

Device Record Status

Public Device Record Key

0081923d-01d9-4f3d-b743-8756494e1154

Public Version Date

February 23, 2021

Public Version Number

1

DI Record Publish Date

February 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DFS - DIAMON GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3171
2 A medical device with a moderate to high risk that requires special controls. 6