3M™ Unitek™ Victory Series™ MBT™ - Victory Series(TM) BuccalTube Mini Single - 3M UNITEK CORPORATION

Duns Number:008256356

Device Description: Victory Series(TM) BuccalTube Mini Single NonConvert Bond LR7 -25T/0 Off 2.5 mm Hk .018 50 Victory Series(TM) BuccalTube Mini Single NonConvert Bond LR7 -25T/0 Off 2.5 mm Hk .018 50/Pk

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More Product Details

Catalog Number

066-4064B

Brand Name

3M™ Unitek™ Victory Series™ MBT™

Version/Model Number

066-4064B

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

DZD

Product Code Name

TUBE, ORTHODONTIC

Device Record Status

Public Device Record Key

f1b762cc-14c9-44b7-beda-948c6e359eb8

Public Version Date

November 19, 2018

Public Version Number

1

DI Record Publish Date

October 18, 2018

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