Screwdriver angled 90° WS-90 - Surgical Handpiece without accessories - W & H Dentalwerk Bürmoos GmbH

Duns Number:300238441

Device Description: Surgical Handpiece without accessories

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More Product Details

Catalog Number

-

Brand Name

Screwdriver angled 90° WS-90

Version/Model Number

30014006

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

5caf4e7e-7884-4760-8ca9-851fc2121eec

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

September 24, 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