3M™ - APC™ PLUS Clarity™ ADVANCED Victory Series™ Low - 3M UNITEK CORPORATION

Duns Number:008256356

Device Description: APC™ PLUS Clarity™ ADVANCED Victory Series™ Low Profile MBT™ Appliance System U/L 022 6x7 APC™ PLUS Clarity™ ADVANCED Victory Series™ Low Profile MBT™ Appliance System U/L 022 6x7 1 Case Kit

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More Product Details

Catalog Number

5006-168

Brand Name

3M™

Version/Model Number

5006-168

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

16a38c8d-f8b1-4961-94e1-cac2e525044b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 01, 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