AccessGUDID - DEVICE: CONSOLE MEG-ENGINE II (J00716011000011)

GUDID

Device Identifier (DI) Information

Brand Name: CONSOLE MEG-ENGINE II
Version or Model: 1601100-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1601100-001
Company Name: Bien-Air Dental SA

Primary DI Number: J00716011000011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480082080 *Terms of Use

Device Description: MEG-ENGINE II is an electrical medical device used to run dental instruments

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?
41264	Surgical power tool system control unit, line-powered	A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBW	Controller, foot, handpiece and cord

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: 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: c31d84ad-5560-4d33-822d-4ec84e4aa9b6
Public Version Date: June 25, 2021
Public Version Number: 1
DI Record Publish Date: June 17, 2021