General Instruments - INSTRUMENT MATHIEU NEEDLE HOLDER SUPER FINE TIPS - AMERICAN ORTHODONTICS CORPORATION

Duns Number:044668515

Device Description: INSTRUMENT MATHIEU NEEDLE HOLDER SUPER FINE TIPS STAINLESS STEEL W/LOCKING

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

010-776

Brand Name

General Instruments

Version/Model Number

010-776

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 24, 2022

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

-

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

JEX

Product Code Name

PLIER, ORTHODONTIC

Device Record Status

Public Device Record Key

59303c8c-e938-4b98-8c07-1742c5082fa4

Public Version Date

May 25, 2022

Public Version Number

2

DI Record Publish Date

August 10, 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