AccessGUDID - DEVICE: OPTIGUIDE® DCYL Cylindrical Diffuser (00376128000100)

GUDID

Device Identifier (DI) Information

Brand Name: OPTIGUIDE® DCYL Cylindrical Diffuser
Version or Model: 220
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pinnacle Biologics, Inc.

Primary DI Number: 00376128000100
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 833037612 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVG	System, Laser, Fiber Optic, Photodynamic Therapy

FDA Premarket Submission

FDA Premarket 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 Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 2.0 Centimeter

Device Record Status

Public Device Record Key: 1397a0a1-1ff4-4553-b55c-6865f596d807
Public Version Date: March 18, 2022
Public Version Number: 5
DI Record Publish Date: September 16, 2014