AccessGUDID - DEVICE: E&Q Master / Pen tip [F] (08806387890355)

GUDID

Device Identifier (DI) Information

Brand Name: E&Q Master / Pen tip [F]
Version or Model: 9035
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Meta Biomed Co., Ltd.

Primary DI Number: 08806387890355
Issuing Agency: GS1
Commercial Distribution End Date: April 11, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 688322841 *Terms of Use

Device Description: Warmed Gutta Percha Obturation System

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):	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?
45247	Endodontic obturation system	An assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation.	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: fc41fdb9-c5c6-4e26-ae3c-059c04f56221
Public Version Date: April 19, 2024
Public Version Number: 2
DI Record Publish Date: May 24, 2021