FDA UDI
In Commercial Distribution
🇺🇸 United States
Photofrin® 630 PDT Laser
DI: 00376128000193
·
Model: BWF5-630-2-PIN
·
Pinnacle Biologics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Photofrin® 630 PDT Laser
- Primary DI
- 00376128000193
- Version / Model
- BWF5-630-2-PIN
- Company Name
- Pinnacle Biologics, Inc.
- Labeler DUNS
- 833037612
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-11
- Public Version
- 1
- Public Version Date
- 2022-03-21
- Public Version Status
- New
- Public Device Record Key
- ab1a63d9-b93e-4a50-bf7e-6bbe4a710d02
Device Description
630 nm Photodynamic Therapy Laser
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 |
|---|---|---|---|---|
| MVF | System, Laser, Photodynamic Therapy | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58866 | Oncological diode laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power [i.e., not considered low-level laser therapy (LLLT)], therapeutic laser beam, typically of visible red-light, intended for oncological photodynamic therapy (PDT) and photochemical internalization (PCI). It is part of a drug-device therapy that combines a pharmaceutical photosensitizer with photoactivation for local cancer treatment. The software-controlled device is designed to deliver cylindrical diffusing outputs and/or frontal diffusing output for surface treatment and/or for interstitial treatment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00376128000193 | GS1 |
Customer Contacts
- Phone
- 1-847-283-7690
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P990021 | 005 |