Henry Schein - Maxima Reamer 21 mm #50 - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Maxima Reamer 21 mm #50

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More Product Details

Catalog Number

5701188

Brand Name

Henry Schein

Version/Model Number

5701188

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

Yes

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

EKP

Product Code Name

REAMER, PULP CANAL, ENDODONTIC

Device Record Status

Public Device Record Key

5395f6fa-a73b-40af-a8de-a358b585beea

Public Version Date

June 28, 2019

Public Version Number

1

DI Record Publish Date

June 20, 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