FDA UDI
In Commercial Distribution
🇺🇸 United States
Planmeca Pro50 Chair
DI: 06430035420964
·
Model: -
·
Planmeca Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Planmeca Pro50 Chair
- Primary DI
- 06430035420964
- Version / Model
- -
- Company Name
- Planmeca Oy
- Labeler DUNS
- 368788568
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-19
- Public Version
- 1
- Public Version Date
- 2022-12-27
- Public Version Status
- New
- Public Device Record Key
- e41883aa-e2eb-4a5d-931e-51ad2ee1761e
Device Description
Planmeca Pro50 Chair is an elegant yet sturdy patient chair with telescopic lifting mechanism. Beautiful and timeless design with metal covers Wide height range from 390 mm to 890 mm Slim backrest and small chair base for optimal access to the treatment area Folding legrest as standard feature Smooth and silent movements with medical grade electrical lifting motors Maximum patient weight: 185 kg
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NRU | Chair, Dental, Without Operative Unit | Dental | 872.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47144 | Dental chair, electric | A mains electricity (AC-powered) device designed to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to several standard positions. Devices intended for dental examination and/or treatment (e.g., lights, irrigation) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06430035420964 | GS1 |