Posterior Band Removing - Replacement Tip - TP ORTHODONTICS INC

Duns Number:005432299

Device Description: Replacement Tip

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More Product Details

Catalog Number

-

Brand Name

Posterior Band Removing

Version/Model Number

100-161

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)

-

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

39e8000c-161d-4e55-9417-1ce853e6726b

Public Version Date

April 23, 2021

Public Version Number

1

DI Record Publish Date

April 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TP ORTHODONTICS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2591
2 A medical device with a moderate to high risk that requires special controls. 715