AccessGUDID - DEVICE: Monoart (E307228102300)

GUDID

Device Identifier (DI) Information

Brand Name: Monoart
Version or Model: MONOART® EM15 SALIVA EJECTOR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22810230
Company Name: EURONDA SPA

Primary DI Number: E307228102300
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428755441 *Terms of Use

Device Description: Disposable, flexible saliva ejectors made of non-toxic, transparent PVC. Fix rounded tips. Integrated metal wire. Diameter 6,5 mm. Bag of 100 pcs. Box of 5.000 pcs. Color: Pink

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?
37434	Dental suction system cannula, single-use	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 typically made of disposable plastic materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYN	Mouthpiece, Saliva Ejector

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: 1d3737c0-4125-44a3-ab63-e3a6991a98b5
Public Version Date: December 11, 2019
Public Version Number: 1
DI Record Publish Date: December 03, 2019