OPTIGUIDE® DCYL Cylindrical Diffuser

Basic Information

• Brand Name: OPTIGUIDE® DCYL Cylindrical Diffuser
• Primary DI: 00376128000087
• Version / Model: 210
• Company Name: Pinnacle Biologics, Inc.
• Labeler DUNS: 833037612
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-16
• Public Version: 5
• Public Version Date: 2022-03-18
• Public Version Status: Update
• Public Device Record Key: d1d50328-d8b8-4505-9661-af130f779737

Device Description

The DYCL series OPTIGUIDE® Fiber Optic Diffuser is a light delivery system consisting of a 400-micron coated silica laser fiber, a proximal SMA-type laser connector, and a distal light diffusing tip (1.65mm diameter).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVG	System, Laser, Fiber Optic, Photodynamic Therapy	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61471	Gastrointestinal photodynamic therapy laser beam guide	A sterile, hand-held, probe-like device intended to be used in conjunction with an oncological laser system for directing and delivering laser energy to the upper gastrointestinal (GI) tract (e.g., oesophagus, stomach, duodenum) during photodynamic therapy (PDT) for local cancer treatment; it is not intended to be used for other laser applications (e.g., ablation, excision, vaporization). It typically consists of a fibreoptic cable with a distal probe inserted via the oral cavity, and is available in a variety of configurations for each section of the upper GI tract. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00376128000087	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P940010	000
P940010	001
P940010	002
P940010	003
P940010	004
P940010	005
P940010	006
P940010	007
P940010	008
P940010	009
P940010	010
P940010	012
P940010	014

Device Sizes

Type	Value	Unit	Text
Length	1.0	Centimeter