Miniscope Telescoping Herbst - MINISCOPE TELESCOPING MECHANISM 24MM RIGHT WITH - AMERICAN ORTHODONTICS CORPORATION

Duns Number:044668515

Device Description: MINISCOPE TELESCOPING MECHANISM 24MM RIGHT WITH ROD CUP

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More Product Details

Catalog Number

855-924RRC

Brand Name

Miniscope Telescoping Herbst

Version/Model Number

855-924RRC

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

DYJ

Product Code Name

RETAINER, SCREW EXPANSION, ORTHODONTIC

Device Record Status

Public Device Record Key

fd3e95fa-3b51-47e7-93b6-491c6ff03b83

Public Version Date

April 11, 2022

Public Version Number

2

DI Record Publish Date

May 12, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMERICAN ORTHODONTICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16634
2 A medical device with a moderate to high risk that requires special controls. 982