GP Cut Replacement Tip Angled - Replacement Tips for the GP Cut Gutta Percha - PRACTICON, INC.

Duns Number:119193803

Device Description: Replacement Tips for the GP Cut Gutta Percha Cutter

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More Product Details

Catalog Number

71-36211 ANG

Brand Name

GP Cut Replacement Tip Angled

Version/Model Number

7136211 ANG

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

EKD

Product Code Name

Instrument, Cutting, Operative

Device Record Status

Public Device Record Key

a87debf6-9df7-4fa2-b0d5-4fdc1fd31023

Public Version Date

August 20, 2018

Public Version Number

1

DI Record Publish Date

July 19, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRACTICON, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 93
2 A medical device with a moderate to high risk that requires special controls. 2