GT Post and Drills - GT Fiber Post 1.25MM - TULSA DENTAL PRODUCTS LLC

Duns Number:942778564

Device Description: GT Fiber Post 1.25MM

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More Product Details

Catalog Number

GTPOSTF2

Brand Name

GT Post and Drills

Version/Model Number

GTPOSTF2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

ELR

Product Code Name

POST, ROOT CANAL

Device Record Status

Public Device Record Key

1a422f4d-5766-4e58-ae50-2deb5b17fad4

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TULSA DENTAL PRODUCTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1973
2 A medical device with a moderate to high risk that requires special controls. 35
U Unclassified 16