Ribbon - TSP Ribbon Mix Syringe Refill - TULSA DENTAL PRODUCTS LLC

Duns Number:942778564

Device Description: TSP Ribbon Mix Syringe Refill

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More Product Details

Catalog Number

RIBFILL

Brand Name

Ribbon

Version/Model Number

RIBFILL

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

Yes

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

KIF

Product Code Name

RESIN, ROOT CANAL FILLING

Device Record Status

Public Device Record Key

7ec10cad-3613-43d4-bbcb-15099f69fd01

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 07, 2016

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