FDA UDI
In Commercial Distribution
🇺🇸 United States
DAAVLIN
DI: 00810182930565
·
Model: Phothera Pro 400
·
DAAVLIN DISTRIBUTING CO., THE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DAAVLIN
- Primary DI
- 00810182930565
- Version / Model
- Phothera Pro 400
- Company Name
- DAAVLIN DISTRIBUTING CO., THE
- Labeler DUNS
- 056696347
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-12
- Public Version
- 1
- Public Version Date
- 2024-12-20
- Public Version Status
- New
- Public Device Record Key
- 5a1a4af7-2cd9-47ca-88aa-d19b6c27e2e9
Device Description
PP400 NBUVB CL 10L
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
- 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
- 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 |
|---|---|---|---|---|
| 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 | 00810182930565 | GS1 |
Customer Contacts
- Phone
- +1(800)322-8546
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220840 | 000 |