Henry Schein - Polycarbonate Crowns - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Polycarbonate Crowns

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


More Product Details

Catalog Number

1009144

Brand Name

Henry Schein

Version/Model Number

1009144

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

ELZ

Product Code Name

CROWN, PREFORMED

Device Record Status

Public Device Record Key

855cdc0d-482d-4d70-bfb3-1e4196390ac7

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

August 24, 2020

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