Polishers - Introductory kit - DFS - DIAMON GmbH

Duns Number:316179456

Device Description: Introductory kit

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More Product Details

Catalog Number

-

Brand Name

Polishers

Version/Model Number

9000650126

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

EHL

Product Code Name

POINT, ABRASIVE

Device Record Status

Public Device Record Key

1b93de54-1c6c-4dad-bb16-a66570f08296

Public Version Date

January 07, 2022

Public Version Number

1

DI Record Publish Date

December 30, 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