AccessGUDID - DEVICE: Monoart (E307220300060)

GUDID

Device Identifier (DI) Information

Brand Name: Monoart
Version or Model: Monoart Bib Up!
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22030006
Company Name: EURONDA SPA

Primary DI Number: E307220300060
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428755441 *Terms of Use

Device Description: Disposable patient protection aprons consisting of a highly absorbent multiple-ply paper embossed with a waterproof polyethylene layer, without the use of glues. Soft and comfortable, compared to traditional towels, they offer larger dimensions and functional contouring on the neck and shoulders for complete patient protection and practical adhesives for fixing. Pack of 150 aprons. Colour: lime.

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?
61048	Patient examination/treatment drape, single-use	A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during an examination or non-surgical treatment procedure in the home or healthcare facility primarily to prevent soiling/cross-contamination; it is not intended for surgical use. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHR	Absorber, Saliva, Paper

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: ee6b8bf2-503c-466c-a69a-6e2b6620cd67
Public Version Date: April 18, 2025
Public Version Number: 1
DI Record Publish Date: April 10, 2025