AccessGUDID - DEVICE: Monoart (E307219101530)

GUDID

Device Identifier (DI) Information

Brand Name: Monoart
Version or Model: MONOART® APRON PG 20 XLong
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21910153
Company Name: EURONDA SPA

Primary DI Number: E307219101530
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428755441 *Terms of Use

Device Description: Roll of 100 patients aprons made from a waterproof polyethylene layer. The perforated tear-off parts make the aprons easy to use. The system with laces, allows to tie apron directly to the patient’s neck. Available in two sizes (120 and 160 cm respectively), these protect patients down to the knee or ankles. Carton of 6 rolls. Dimensions: 160 x 53 cm. Colour: blue.

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: 9c3bdbf6-0203-4aad-833e-6dadb90173be
Public Version Date: June 26, 2020
Public Version Number: 1
DI Record Publish Date: June 18, 2020