3M™ Unitek™ - Modified Arrowhead Clasp 5.5 mm x .024 10/Pk - 3M UNITEK CORPORATION

Duns Number:008256356

Device Description: Modified Arrowhead Clasp 5.5 mm x .024 10/Pk

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More Product Details

Catalog Number

362-241

Brand Name

3M™ Unitek™

Version/Model Number

362-241

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

DZC

Product Code Name

WIRE, ORTHODONTIC

Device Record Status

Public Device Record Key

b20e1b33-11c9-4f7d-a0fb-6ad13bb4dfd7

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