Mojave Mobile - Mobile dental suction system - DÜRR DENTAL SE

Duns Number:315563684

Device Description: Mobile dental suction system

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More Product Details

Catalog Number

-

Brand Name

Mojave Mobile

Version/Model Number

E247ATH7200200

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

NRD

Product Code Name

Unit, Operative Dental, Accessories

Device Record Status

Public Device Record Key

4a0f286d-a044-4ab4-8508-44cb91c7171e

Public Version Date

July 03, 2020

Public Version Number

1

DI Record Publish Date

June 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DÜRR DENTAL SE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 28