Masterline - INSTRUMENT MASTERLINE THREE JAW STRAIGHT PLIERS - AMERICAN ORTHODONTICS CORPORATION

Duns Number:044668515

Device Description: INSTRUMENT MASTERLINE THREE JAW STRAIGHT PLIERS

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More Product Details

Catalog Number

001-033959

Brand Name

Masterline

Version/Model Number

001-033959

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 27, 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

a2b92517-9553-4262-819f-99217cf1debe

Public Version Date

May 27, 2022

Public Version Number

2

DI Record Publish Date

August 18, 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