FDA UDI
In Commercial Distribution
🇺🇸 United States
BF-RhodoLED
DI: 04260308240102
·
Model: US
·
Biofrontera Pharma GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BF-RhodoLED
- Primary DI
- 04260308240102
- Version / Model
- US
- Company Name
- Biofrontera Pharma GmbH
- Labeler DUNS
- 332358501
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-13
- Public Version
- 1
- Public Version Date
- 2019-09-23
- Public Version Status
- New
- Public Device Record Key
- 5685ccfd-7eba-4879-a501-e38a1eecd187
Device Description
BF-RhodoLED® is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydrochloride) gel, 10% for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MYH | System,Non-Coherent Light,Photodynamic Therapy | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59739 | Skin photodynamic therapy lamp | A mobile, mains electricity (AC-powered) lamp intended to emit red light of high stability with a narrow spectrum (e.g., 630nm) for photodynamic therapy (PDT) applications on multiple anatomical sites (e.g., face, torso) to treat skin disorders such as non-melanoma skin cancer and precancerous lesions of the skin. As a component of a drug-device combination therapy it is designed to selectively activate a photosensitizing agent at the specific anatomical site requiring treatment, thus providing anatomically specific PDT. This device is intended to be used by a healthcare professional in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260308240102 | GS1 |
Customer Contacts
- Phone
- 781-245-1325
- [email protected]