Essentials - Essentials Pro 2SM Handpiece - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Essentials Pro 2SM Handpiece

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More Product Details

Catalog Number

5701434

Brand Name

Essentials

Version/Model Number

5701434

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

EFB

Product Code Name

Handpiece, air-powered, dental

Device Record Status

Public Device Record Key

69af0f4c-7ae6-4122-a9ea-b27129e39281

Public Version Date

December 04, 2019

Public Version Number

1

DI Record Publish Date

November 26, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HENRY SCHEIN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3829
2 A medical device with a moderate to high risk that requires special controls. 2579
3 A medical device with high risk that requires premarket approval 1
U Unclassified 34