AccessGUDID - DEVICE: Monoart (E307229310080)

GUDID

Device Identifier (DI) Information

Brand Name: Monoart
Version or Model: MONOART EM21
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22931008
Company Name: EURONDA SPA

Primary DI Number: E307229310080
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428755441 *Terms of Use

Device Description: Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilizedin autoclaves at up to 134°C. Connection diameter:16 mm. Length: 129 mm. Box of 10 pieces of the same colour. Colour: green

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:	Yes
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?
38759	Dental suction system cannula, reusable	A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEA	Cannula, Surgical, General & Plastic Surgery

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: 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: 36901029-7f26-47ed-b487-d3a3d43944b1
Public Version Date: December 16, 2019
Public Version Number: 1
DI Record Publish Date: December 06, 2019