FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Planmeca Chair
DI: 06430035420162
·
Model: Chair
·
Planmeca Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Planmeca Chair
- Primary DI
- 06430035420162
- Version / Model
- Chair
- Catalog Number
- 10026000
- Company Name
- Planmeca Oy
- Labeler DUNS
- 368788568
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-08
- Public Version
- 4
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- 0346cf77-4329-45ca-9373-05887c200dbb
- Distribution End Date
- 2021-04-28
Device Description
Planmeca Chair is electronically controlled patient chair with swivel funcion allowing the chair to be swivelled 90 degrees to left and right. The chair has an integrated foot control for automatic chair positions and manual movements. The chair can be equipped with optional foldable knee-break.
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
- No
- 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 |
|---|---|---|---|---|
| KLC | Chair, Dental, With 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 | 06430035420162 | GS1 |