INTEGO pro CS ambidextrous - Treatment Center INTEGO pro CS ambidextrous with - SIRONA Dental Systems GmbH

Duns Number:340306351

Device Description: Treatment Center INTEGO pro CS ambidextrous with water bottle

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More Product Details

Catalog Number

-

Brand Name

INTEGO pro CS ambidextrous

Version/Model Number

6591882

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

EBW

Product Code Name

Controller, Foot, Handpiece And Cord

Device Record Status

Public Device Record Key

be33e528-b8a3-486a-893b-c1ba70b16de2

Public Version Date

May 17, 2022

Public Version Number

5

DI Record Publish Date

September 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIRONA DENTAL SYSTEMS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 235
2 A medical device with a moderate to high risk that requires special controls. 326