Henry Schein - Maxima Gutta Percha Points CC - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Maxima Gutta Percha Points CC

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More Product Details

Catalog Number

1015143

Brand Name

Henry Schein

Version/Model Number

1015143

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

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

EKM

Product Code Name

GUTTA-PERCHA

Device Record Status

Public Device Record Key

27f51e24-0bd2-4d5f-9b87-46486aa9251b

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 15, 2022

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