FDA UDI
In Commercial Distribution
🇺🇸 United States
MULTIFUNCTION TABLE
DI: 08055715707050
·
Model: TAVOLO MULTIFUNZIONE MIS LARGE
·
ORMESA SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MULTIFUNCTION TABLE
- Primary DI
- 08055715707050
- Version / Model
- TAVOLO MULTIFUNZIONE MIS LARGE
- Company Name
- ORMESA SRL
- Labeler DUNS
- 432070019
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-31
- Public Version
- 1
- Public Version Date
- 2025-02-10
- Public Version Status
- New
- Public Device Record Key
- 1a418935-c3a2-4032-a2fd-335382de218b
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| INW | Table, Mechanical | Physical Medicine | 890.3750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08055715707050 | GS1 |