3M™ - APC™ Flash-Free Clarity™ ADVANCED MBT™ Appliance - 3M UNITEK CORPORATION

Duns Number:008256356

Device Description: APC™ Flash-Free Clarity™ ADVANCED MBT™ Appliance System U/L 6x7 022 1 Case Kit CHk

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More Product Details

Catalog Number

4006-171

Brand Name

3M™

Version/Model Number

4006-171

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

DYH

Product Code Name

ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Device Record Status

Public Device Record Key

c5ba6b06-d793-41fe-a9be-4a9c0a2974a3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 25, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"3M UNITEK CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 30
2 A medical device with a moderate to high risk that requires special controls. 610