AccessGUDID - DEVICE: MULTIFUNCTION TABLE (08055715707067)

GUDID

Device Identifier (DI) Information

Brand Name: MULTIFUNCTION TABLE
Version or Model: TAVOLO MULTIFUNZIONE MIS MEDIUM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORMESA SRL

Primary DI Number: 08055715707067
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432070019 *Terms of Use

Device Description: Provides a large, ergonomic and functional support surface for manual activities or reading, adaptable to the position chosen by the user (sitting, standing / vertical or prone) and which allows the approach not only to normal chairs, but also to more specific seating systems. Intended for children and adults with moderate to complex motor or cognitive impairment and who need a reference plan for carrying out teaching, training and / or work activities, as a complement to other devices such as seats and / or high chairs.

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:	No
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?
31219	Ergonomic workdesk, manual	A manually-operated desk designed with ergonomic adjustments to provide improved personal work-position flexibility and to help prevent/reduce physical problems associated with sedentary work. It is intended to be used for work or training typically by patients with back problems or disabilities. It typically includes a mechanical height-adjustable worktop and may include tilting-functions or raised table edges; it is typically used for computer and writing work in an office, school, or home setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INW	Table, Mechanical

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: 7c4f81be-5c27-4f4d-b57b-80e66bdb0a2d
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: January 31, 2025