Nu-Edge Cobalt Chromium Brackets - LL 1st BI W/DISTAL HK - TP ORTHODONTICS INC

Duns Number:005432299

Device Description: LL 1st BI W/DISTAL HK

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More Product Details

Catalog Number

-

Brand Name

Nu-Edge Cobalt Chromium Brackets

Version/Model Number

293-3701

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

EJF

Product Code Name

BRACKET, METAL, ORTHODONTIC

Device Record Status

Public Device Record Key

8e2d987a-21d3-41a6-bc24-0c526a7827c8

Public Version Date

February 09, 2022

Public Version Number

1

DI Record Publish Date

February 01, 2022

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