OPTIGUIDE® Cylindrical Diffuser
GUDID 00376128000346
1.0cm Flexible fiber optic diffuser for use in photodynamic therapy
Pinnacle Biologics, Inc.
Gastrointestinal photodynamic therapy laser beam guide| Primary Device ID | 00376128000346 |
| NIH Device Record Key | 980aaff9-7a28-483a-9143-fad564d17d84 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTIGUIDE® Cylindrical Diffuser |
| Version Model Number | 710 |
| 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 | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
| Length | 1 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00376128000346 [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 | 2019-11-14 |
| Device Publish Date | 2019-11-06 |
On-Brand Devices [OPTIGUIDE® Cylindrical Diffuser]
| 00376128000346 | 1.0cm Flexible fiber optic diffuser for use in photodynamic therapy |
| 00376128000391 | 5.0cm Flexible fiber optic diffuser for use in photodynamic therapy |
| 00376128000384 | 3.0cm Flexible fiber optic diffuser for use in photodynamic therapy |
| 00376128000377 | 2.5cm Flexible fiber optic diffuser for use in photodynamic therapy |
| 00376128000360 | 2.0cm Flexible fiber optic diffuser for use in photodynamic therapy |
| 00376128000353 | 1.5cm Flexible 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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