Henry Schein - PREMIUM DNT BASE 99 HC (5 LBS 4 PER CASE) - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: PREMIUM DNT BASE 99 HC (5 LBS 4 PER CASE)

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More Product Details

Catalog Number

1019276

Brand Name

Henry Schein

Version/Model Number

1019276

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EBI

Product Code Name

RESIN, DENTURE, RELINING, REPAIRING, REBASING

Device Record Status

Public Device Record Key

6e1d8a9a-02da-45fd-acae-2a5aaa7f1891

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

H65810192761

Quantity per Package

4

Contains DI Package

H65810192760

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