Symetri Clear - U3L SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI - ORMCO CORPORATION

Duns Number:154614119

Device Description: U3L SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI .022 0/8/0 W/HOOK

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More Product Details

Catalog Number

-

Brand Name

Symetri Clear

Version/Model Number

419-2311

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

NJM

Product Code Name

Bracket, Ceramic, Orthodontic

Device Record Status

Public Device Record Key

902f05d7-80f6-4330-8af2-2046d55cbed2

Public Version Date

April 16, 2018

Public Version Number

1

DI Record Publish Date

March 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORMCO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28
2 A medical device with a moderate to high risk that requires special controls. 199