FDA UDI
In Commercial Distribution
🇺🇸 United States
GRILLO CHAIR
DI: 08055715708347
·
Model: GRILLO CHAIR ROSA mis.MEDIUM
·
ORMESA SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GRILLO CHAIR
- Primary DI
- 08055715708347
- Version / Model
- GRILLO CHAIR ROSA mis.MEDIUM
- 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
- 526fa67d-2211-49cc-b704-c4a0c800b930
Device Description
Ergonomic and adjustable chair suitable for children with disabilities who need support during recreational, educational and daily life activities. It is an ergonomically designed seat designed to ensure maximum comfort for the child who, by improving their sitting posture, is encouraged to develop motor skills and hand-eye coordination, attention and therefore social inclusion.
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 |
|---|---|---|---|---|
| INN | Chair, Adjustable, Mechanical | Physical Medicine | 890.3100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58827 | Assistive ergonomic chair, manually-adjusted | A non-electrical device, that may include pneumatically-assisted features, intended to support and position a patient (disabled and/or discomforted) in a sitting posture while performing activities of daily living, including work-related activities. It is designed with manually-operated ergonomic adjustments (e.g., height and position adjustments) to provide improved personal body posture and/or to help prevent/reduce physical problems associated with poor mobility or sedentary lifestyle. It is not a wheelchair. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08055715708347 | GS1 |