FDA UDI
In Commercial Distribution
🇺🇸 United States
Enhanced AURORA™ Medical Diode System, and related accessories
DI: B780AUR20000
·
Model: 2000
·
PSORIA-SHIELD INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Enhanced AURORA™ Medical Diode System, and related accessories
- Primary DI
- B780AUR20000
- Version / Model
- 2000
- Company Name
- PSORIA-SHIELD INC.
- Labeler DUNS
- 962442633
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-12
- Public Version
- 2
- Public Version Date
- 2023-08-09
- Public Version Status
- Update
- Public Device Record Key
- 1e111896-8c97-4deb-a335-a3952fe64448
Device Description
The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
| FTC | Light, Ultraviolet, Dermatological | General, Plastic Surgery | 878.4630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35149 | Ultraviolet phototherapy unit, professional | A mains electricity (AC-powered) device with special lamps that emit ultraviolet B (UVB), or UVB and ultraviolet A (UVA) radiation intended to be used by a healthcare professional to treat a variety of dermatological disorders (e.g., psoriasis). The device is typically designed as a flat surface for lying with an overhead lamp(s), or as a chamber/cabinet, in which the patient stands, with interior walls lined with ultraviolet (UV) light tubes to allow full-body exposure and an even distribution of UV radiation. The device intended use may include psoralen + UVA therapy (oral administration of psoralen and subsequent exposure to UVA) (PUVA). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B780AUR20000 | HIBCC |