First Molar Triple Tubes - UL 1st Molar W/HK - TP ORTHODONTICS INC

Duns Number:005432299

Device Description: UL 1st Molar W/HK Torque 0, Tip 0, Distal Offset 0 UL 1st Molar W/HK Torque 0, Tip 0, Distal Offset 0 0.46 mm x 0.64mm (.018" x .025") 4.5 mm

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More Product Details

Catalog Number

-

Brand Name

First Molar Triple Tubes

Version/Model Number

391-361

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

DZD

Product Code Name

TUBE, ORTHODONTIC

Device Record Status

Public Device Record Key

bb7a4996-ca46-45ac-8490-662212eb7929

Public Version Date

March 23, 2021

Public Version Number

1

DI Record Publish Date

March 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