Evogue Dental Unit - Evogue Dental Unit PMU - TAKARA-BELMONT CO., LTD.

Duns Number:690540349

Device Description: Evogue Dental Unit PMU

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More Product Details

Catalog Number

AU-HV3115C

Brand Name

Evogue Dental Unit

Version/Model Number

Evogue Dental Unit

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K152100

Product Code Details

Product Code

EIA

Product Code Name

Unit, Operative Dental

Device Record Status

Public Device Record Key

846e7b78-fe6c-4cbc-8580-d811cb5ae3e3

Public Version Date

May 27, 2022

Public Version Number

2

DI Record Publish Date

November 20, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TAKARA-BELMONT CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 72
2 A medical device with a moderate to high risk that requires special controls. 19