AccessGUDID - DEVICE: GPRO (00990010302204)

GUDID

Device Identifier (DI) Information

Brand Name: GPRO
Version or Model: GP2002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GPRO F1
Company Name: Beyes Dental Canada Inc

Primary DI Number: 00990010302204
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 244261462 *Terms of Use

Device Description: GPRO F1,Gutta-percha Obturation Filling Machine Tips included: 1x 23G 24mm, 1x 23G 28mm, 2x 25G 24mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	Yes
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?
45250	Endodontic obturation system handpiece, material extrusion	A handpiece, which is part of an endodontic obturation system, intended to backfill and down pack gutta-percha (extrude) during root canal treatment or root canal obturation. Resistive heat is applied through this device around a heat chamber to heat up a cartridge of gutta-percha. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKR	Plugger, Root Canal, Endodontic

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 705692a8-ec93-479c-8fbd-e5a231403417
Public Version Date: May 19, 2023
Public Version Number: 1
DI Record Publish Date: May 11, 2023