AccessGUDID - DEVICE: Monoart (E307220103140)

GUDID

Device Identifier (DI) Information

Brand Name: Monoart
Version or Model: MONOART APRON PG30
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22010314
Company Name: EURONDA SPA

Primary DI Number: E307220103140
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428755441 *Terms of Use

Device Description: Roll of 60 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 810 x 530 mm. Carton of 6 rolls. Colour: lilac

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: 99c69ec1-b60b-4f8f-8e83-a20047df9d4e
Public Version Date: December 24, 2019
Public Version Number: 1
DI Record Publish Date: December 16, 2019