3M™ Unitek™ Victory Series™ - Victory Series(TM) Bracket Sondhi UL2 14T/8A Hk - 3m do Brasil Ltda.

Duns Number:901611820

Device Description: Victory Series(TM) Bracket Sondhi UL2 14T/8A Hk .022 50/Pk

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More Product Details

Catalog Number

017-671B

Brand Name

3M™ Unitek™ Victory Series™

Version/Model Number

017-671B

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

EJF

Product Code Name

BRACKET, METAL, ORTHODONTIC

Device Record Status

Public Device Record Key

b114e7f4-5777-4607-a7b1-e29c5eb0bcec

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"3M DO BRASIL LTDA." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33