AccessGUDID - DEVICE: GP Cut Gutta Percha Cutter (00723896005361)

GUDID

Device Identifier (DI) Information

Brand Name: GP Cut Gutta Percha Cutter
Version or Model: 1362
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71-36210
Company Name: PRACTICON, INC.

Primary DI Number: 00723896005361
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Cut gutta percha quickly, cleanly, and safely within the pulp chamber with the cordless GP Cut Gutta Percha Cutter. Hold the power button for one second and the tip will reach up to 1,000°C. Release the button, and the tip cools down in less than one second. Bendable, flexible tips come in three sizes: large (2.0mm wide), medium (1.2mm wide), and small (0.5mm wide). The GP Cut system comes complete with one unit, one base, protective cap, and three tips (one of each size). 7.875" long x .75" wide. Powered by two AA batteries

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41876	Endodontic plugger	A hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKD	Instrument, Cutting, Operative

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 11eb1e1b-e95d-476f-a843-49685de1761c
Public Version Date: June 13, 2023
Public Version Number: 2
DI Record Publish Date: July 19, 2018