Photofrin® 630 PDT Laser
GUDID 00376128000155
630nm Photodynamic Therapy Laser
Pinnacle Biologics, Inc.
Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system Oncological diode laser system| Primary Device ID | 00376128000155 |
| NIH Device Record Key | 97207275-94c6-48ad-967a-d34e8e210ab1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Photofrin® 630 PDT Laser |
| Version Model Number | 63001 |
| Company DUNS | 833037612 |
| Company Name | Pinnacle Biologics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00376128000155 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P990021
FDA Product Code
| MVF | System, Laser, Photodynamic Therapy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-19 |
On-Brand Devices [Photofrin® 630 PDT Laser]
| 00376128000179 | 630nm Photodynamic Therapy Laser |
| 00376128000155 | 630nm Photodynamic Therapy Laser |
| 00376128000193 | 630 nm Photodynamic Therapy Laser |
Trademark Results [Photofrin]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PHOTOFRIN 73437839 1367281 Live/Registered |
ONCOLOGY RESEARCH & DEVELOPMENT, INC. 1983-08-04 |
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