MEDIDENTA - MEDILECTRIC ELECTRIC HANDPIECE SYSTEM - HANDPIECE PARTS & REPAIRS, INC.

Duns Number:079723355

Device Description: MEDILECTRIC ELECTRIC HANDPIECE SYSTEM

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More Product Details

Catalog Number

EJ0008-MEDI

Brand Name

MEDIDENTA

Version/Model Number

EJ0008-MEDI

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

-

Product Code Details

Product Code

EBW

Product Code Name

Controller, Foot, Handpiece And Cord

Device Record Status

Public Device Record Key

17e249b0-e5c6-41ec-bf36-9c096a394114

Public Version Date

May 30, 2022

Public Version Number

1

DI Record Publish Date

May 20, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HANDPIECE PARTS & REPAIRS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 68