AccessGUDID - DEVICE: Cybird (08800017900018)

GUDID

Device Identifier (DI) Information

Brand Name: Cybird
Version or Model: GOLD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GOLD
Company Name: DXM CO., LTD

Primary DI Number: 08800017900018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688797315 *Terms of Use

Device Description: This dental device is a curing unit intended for polymerization of light-cured materials by dental professionals.

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?
35775	Dental/surgical polymerization lamp	A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBZ	Activator, Ultraviolet, For Polymerization

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Handling Environment Temperature: between -5 and 40 Degrees Celsius
Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Storage Environment Temperature: between -10 and 45 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 60 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 71fa7768-a12b-43cb-99e5-170ce464a2db
Public Version Date: June 20, 2023
Public Version Number: 4
DI Record Publish Date: February 01, 2017