Optiguide® Cylindrical Fiber Optic Diffuser
GUDID 00376128000261
5.0cm rigid fiber optic diffuser for use in photodynamic therapy.
Pinnacle Biologics, Inc.
Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide Gastrointestinal photodynamic therapy laser beam guide| Primary Device ID | 00376128000261 |
| NIH Device Record Key | 65885a19-ab7c-4caf-923f-5b4c47365672 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Optiguide® Cylindrical Fiber Optic Diffuser |
| Version Model Number | 250 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
| Length | 5 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00376128000261 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P940010
FDA Product Code
| MVG | System, Laser, Fiber Optic, Photodynamic Therapy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-09 |
| Device Publish Date | 2019-08-30 |
On-Brand Devices [Optiguide® Cylindrical Fiber Optic Diffuser]
| 00376128000278 | 3.0cm rigid fiber optic diffuser for use in photodynamic therapy. |
| 00376128000261 | 5.0cm rigid fiber optic diffuser for use in photodynamic therapy. |
| 00376128000254 | 2.5cm rigid fiber optic diffuser for use in photodynamic therapy. |
| 00376128000247 | 2.0cm rigid fiber optic diffuser for use in photodynamic therapy. |
| 00376128000230 | 1.5cm rigid fiber optic diffuser for use in photodynamic therapy. |
| 00376128000223 | 1.0cm rigid fiber optic diffuser for use in photodynamic therapy. |
Trademark Results [Optiguide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTIGUIDE 85387595 4896952 Live/Registered |
SiCat GmbH & Co KG 2011-08-02 |
 OPTIGUIDE 79033759 3501941 Dead/Cancelled |
Siemens S.A.S. 2006-09-19 |
 OPTIGUIDE 76247948 2706195 Dead/Cancelled |
SIEMENS ENTERPRISE COMMUNICATIONS GMBH & CO. KG 2001-04-27 |
 OPTIGUIDE 75901981 not registered Dead/Abandoned |
POLY-OPTICAL PRODUCTS, lNC. 2000-01-24 |
 OPTIGUIDE 75597117 2361601 Dead/Cancelled |
Reishauer AG 1998-11-30 |
 OPTIGUIDE 74502189 2055737 Live/Registered |
CONCORDIA LABORATORIES INC. 1994-03-16 |
 OPTIGUIDE 74101350 1656132 Dead/Cancelled |
Millitech Corporation 1990-09-28 |
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