AccessGUDID - DEVICE: Monoart (E3072620100)

GUDID

Device Identifier (DI) Information

Brand Name: Monoart
Version or Model: MONOART BANDANA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 262010
Company Name: EURONDA SPA

Primary DI Number: E3072620100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428755441 *Terms of Use

Device Description: This Personal Protective Equipment (P.P.E.) is designed and manufactured exclusively to protect the user against minor or easily reversible impacts resulting from the use of mechanical equipment and/or cleaning products. This P.P.E. also protects against: risks due to contact with hot components having a temperature not exceeding 50°C (normal environmental conditions when working); minor impacts. It is not suitable to protect against the following risks: chemical, heat, fire, cold, poor visibility and electric shock. Monoart bandana with adjustable ties that can fit all sizes. Thanks to the top-quality, colour-fast cotton used, it is autoclavable at 121°C. Single pack, carton of 10 pieces of the same colour. Colour: black

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?
38260	Surgical cap, reusable	A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of woven materials. This is a reusable garment intended to be laundered after each use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYF	Cap, Surgical

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: decc4e70-b52a-4f53-b4e0-bc36b2d2568b
Public Version Date: December 22, 2021
Public Version Number: 2
DI Record Publish Date: December 17, 2019