Photofrin® 630 PDT Laser
GUDID 00376128000155
630nm Photodynamic Therapy Laser
Pinnacle Biologics, Inc.
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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