Miniscope Telescoping Herbst - MINISCOPE KIT WITH ROLLO BANDS - AMERICAN ORTHODONTICS CORPORATION

Duns Number:044668515

Device Description: MINISCOPE KIT WITH ROLLO BANDS

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More Product Details

Catalog Number

855-920

Brand Name

Miniscope Telescoping Herbst

Version/Model Number

855-920

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 06, 2021

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

4948c2e9-b762-435c-bda1-4b6ccd5b5e81

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

September 04, 2020

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