Henry Schein - Etch Gel Jumbo Syringe Refill 40%, 1x60gm syringe - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Etch Gel Jumbo Syringe Refill 40%, 1x60gm syringe

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More Product Details

Catalog Number

5702000

Brand Name

Henry Schein

Version/Model Number

5702000

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

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Device Record Status

Public Device Record Key

d9f4a48a-5479-4458-8cc4-11094daf30ef

Public Version Date

May 20, 2020

Public Version Number

1

DI Record Publish Date

May 12, 2020

Additional Identifiers

Package DI Number

10304040132149

Quantity per Package

10

Contains DI Package

00304040132142

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"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