AccessGUDID - DEVICE: Maint Aquacare (Single Can) (J00716006170011)

GUDID

Device Identifier (DI) Information

Brand Name: Maint Aquacare (Single Can)
Version or Model: 1600617-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1600617-001
Company Name: Bien-Air Dental SA

Primary DI Number: J00716006170011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480082080 *Terms of Use

Device Description: Maintenance products (cleaning the device and lubricate the active parts as ball bearings)are intended for use in dentistry by professional users, to maintain the proper and safe functioning of the 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?
15772	Surgical instrument maintenance lubricant	A non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFB	Handpiece, air-powered, dental

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 730a9ac3-a17a-487b-b25f-aff6afe4e085
Public Version Date: July 02, 2021
Public Version Number: 3
DI Record Publish Date: June 17, 2021