Burkhart Flowable Composite A3.5 Syringe 1ML SYR/5-20G Tips - BURKHART DENTAL SUPPLY CO., THE

Duns Number:027532357

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More Product Details

Catalog Number

-

Brand Name

Burkhart Flowable Composite A3.5 Syringe 1ML SYR/5-20G Tips

Version/Model Number

72720396

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)

-

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

03d40c25-4e22-4a51-89a8-1dfe4295b4f8

Public Version Date

November 08, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

00854212006226

Quantity per Package

3

Contains DI Package

00854212006219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BURKHART DENTAL SUPPLY CO., THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 214
2 A medical device with a moderate to high risk that requires special controls. 43