Henry Schein - Maxima Diamond FG 886-014C - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Maxima Diamond FG 886-014C

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

9007408

Brand Name

Henry Schein

Version/Model Number

9007408

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

DZP

Product Code Name

INSTRUMENT, DIAMOND, DENTAL

Device Record Status

Public Device Record Key

7812f254-6b7e-48a7-be1c-2f5d0b5e3cb9

Public Version Date

March 23, 2020

Public Version Number

2

DI Record Publish Date

December 30, 2019

Additional Identifiers

Package DI Number

20304040035386

Quantity per Package

10

Contains DI Package

10304040035389

Package Discontinue Date

-

Package Status

In Commercial Distribution

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