WI-75 LED G IMPLANTOL.NOUVAG - Surgical Handpiece - W & H Dentalwerk Bürmoos GmbH

Duns Number:300238441

Device Description: Surgical Handpiece

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More Product Details

Catalog Number

-

Brand Name

WI-75 LED G IMPLANTOL.NOUVAG

Version/Model Number

10207568

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)

Yes

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

KMW

Product Code Name

Handpiece, Rotary Bone Cutting

Device Record Status

Public Device Record Key

43102694-80c6-40ad-ba96-e349da4acf6f

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

September 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"W & H DENTALWERK BÜRMOOS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 343
2 A medical device with a moderate to high risk that requires special controls. 87