Burkhart Cover Film Blue 4X6 (1200) - BURKHART DENTAL SUPPLY CO., THE

Duns Number:027532357

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More Product Details

Catalog Number

-

Brand Name

Burkhart Cover Film Blue 4X6 (1200)

Version/Model Number

72720371

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

MMP

Product Code Name

Cover, Barrier, Protective

Device Record Status

Public Device Record Key

3e7f0fba-872a-431b-9ac7-81105f75d1e8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

10854212006711

Quantity per Package

12

Contains DI Package

00854212006714

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