FDA.reportPublic FDA data

Optiguide® Cylindrical Fiber Optic Diffuser

Primary DI
00376128000254
Brand
Optiguide® Cylindrical Fiber Optic Diffuser
Company
Pinnacle Biologics, Inc.
Model
225
Device description
2.5cm rigid fiber optic diffuser for use in photodynamic therapy.
Published
2019-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVGSystem, Laser, Fiber Optic, Photodynamic Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVGSystem, Laser, Fiber Optic, Photodynamic TherapyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P940010001
P940010002
P940010003
P940010004
P940010005
P940010006
P940010007
P940010008
P940010009
P940010010

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P940010001OPTIGUIDE(TM) FIBER OPTIC DIFFUSERPinnacle Biologics, Inc.1995-12-27MVG
P940010002OPTIGUIDE(TM) FIBER OPTIC DIFFUSERPinnacle Biologics, Inc.1995-12-27MVG
P940010003OPTIGUIDE(TM) FIBER OPTIC DIFFUSERPinnacle Biologics, Inc.1995-12-27MVG
P940010004OPTIGUIDE(TM) FIBER OPTIC DIFFUSERPinnacle Biologics, Inc.1995-12-27MVG
P940010005OPTIGUIDE(TM) FIBER OPTIC DIFFUSERPinnacle Biologics, Inc.1995-12-27MVG
P940010006OPTIGUIDE(TM) FIBER OPTIC DIFFUSERPinnacle Biologics, Inc.1995-12-27MVG
P940010007OPTIGUIDE(TM) FIBER OPTIC DIFFUSERPinnacle Biologics, Inc.1995-12-27MVG
P940010008OPTIGUIDE(TM) FIBER OPTIC DIFFUSERPinnacle Biologics, Inc.1995-12-27MVG
P940010009OPTIGUIDE(TM) FIBER OPTIC DIFFUSERPinnacle Biologics, Inc.1995-12-27MVG
P940010010OPTIGUIDE(TM) FIBER OPTIC DIFFUSERPinnacle Biologics, Inc.1995-12-27MVG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00376128000254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00376128000254003761280002543761280002540376128000254

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal photodynamic therapy laser beam guideA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8472837690productinfo@concordialaboratories.com
1-866-248-2039productinfo@concordialaboratories.com

Regulatory Flags#

DUNS number
833037612
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00376128000193Photofrin® 630 PDT Laser BWF5-630-2-PIN2022-03-11
00376128000223Optiguide® Cylindrical Fiber Optic Diffuser2102019-08-30
00376128000230Optiguide® Cylindrical Fiber Optic Diffuser2152019-08-30
00376128000247Optiguide® Cylindrical Fiber Optic Diffuser2202019-08-30
00376128000261Optiguide® Cylindrical Fiber Optic Diffuser2502019-08-30
00376128000278Optiguide® Cylindrical Fiber Optic Diffuser2302019-08-30
00376128000353OPTIGUIDE® Cylindrical Diffuser7152019-11-07
00376128000360OPTIGUIDE® Cylindrical Diffuser7202019-11-07
00376128000377OPTIGUIDE® Cylindrical Diffuser7252019-11-07
00376128000384OPTIGUIDE® Cylindrical Diffuser7302019-11-07
00376128000391OPTIGUIDE® Cylindrical Diffuser7502019-11-07
00376128000346OPTIGUIDE® Cylindrical Diffuser7102019-11-06
00376128000018OPTIGUIDE® DCYL Cylindrical Diffuser7102014-09-16
00376128000025OPTIGUIDE® DCYL Cylindrical Diffuser7202014-09-16
00376128000032OPTIGUIDE® DCYL Cylindrical Diffuser7152014-09-16
00376128000049OPTIGUIDE® DCYL Cylindrical Diffuser7302014-09-16
00376128000056OPTIGUIDE® DCYL Cylindrical Diffuser7252014-09-16
00376128000063OPTIGUIDE® DCYL Cylindrical Diffuser7402014-09-16
00376128000070OPTIGUIDE® DCYL Cylindrical Diffuser7502014-09-16
00376128000087OPTIGUIDE® DCYL Cylindrical Diffuser2102014-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00376128000353OPTIGUIDE® Cylindrical DiffuserPinnacle Biologics, Inc.MVG2019-11-07
00376128000360OPTIGUIDE® Cylindrical DiffuserPinnacle Biologics, Inc.MVG2019-11-07
00376128000377OPTIGUIDE® Cylindrical DiffuserPinnacle Biologics, Inc.MVG2019-11-07
00376128000384OPTIGUIDE® Cylindrical DiffuserPinnacle Biologics, Inc.MVG2019-11-07
00376128000391OPTIGUIDE® Cylindrical DiffuserPinnacle Biologics, Inc.MVG2019-11-07
00376128000346OPTIGUIDE® Cylindrical DiffuserPinnacle Biologics, Inc.MVG2019-11-06
00376128000223Optiguide® Cylindrical Fiber Optic DiffuserPinnacle Biologics, Inc.MVG2019-08-30
00376128000230Optiguide® Cylindrical Fiber Optic DiffuserPinnacle Biologics, Inc.MVG2019-08-30
00376128000247Optiguide® Cylindrical Fiber Optic DiffuserPinnacle Biologics, Inc.MVG2019-08-30
00376128000261Optiguide® Cylindrical Fiber Optic DiffuserPinnacle Biologics, Inc.MVG2019-08-30
00376128000278Optiguide® Cylindrical Fiber Optic DiffuserPinnacle Biologics, Inc.MVG2019-08-30
00376128000018OPTIGUIDE® DCYL Cylindrical DiffuserPinnacle Biologics, Inc.MVG2014-09-16
00376128000025OPTIGUIDE® DCYL Cylindrical DiffuserPinnacle Biologics, Inc.MVG2014-09-16
00376128000032OPTIGUIDE® DCYL Cylindrical DiffuserPinnacle Biologics, Inc.MVG2014-09-16
00376128000049OPTIGUIDE® DCYL Cylindrical DiffuserPinnacle Biologics, Inc.MVG2014-09-16
00376128000056OPTIGUIDE® DCYL Cylindrical DiffuserPinnacle Biologics, Inc.MVG2014-09-16
00376128000063OPTIGUIDE® DCYL Cylindrical DiffuserPinnacle Biologics, Inc.MVG2014-09-16
00376128000070OPTIGUIDE® DCYL Cylindrical DiffuserPinnacle Biologics, Inc.MVG2014-09-16
00376128000087OPTIGUIDE® DCYL Cylindrical DiffuserPinnacle Biologics, Inc.MVG2014-09-16
00376128000094OPTIGUIDE® DCYL Cylindrical DiffuserPinnacle Biologics, Inc.MVG2014-09-16
00376128000100OPTIGUIDE® DCYL Cylindrical DiffuserPinnacle Biologics, Inc.MVG2014-09-16
00376128000117OPTIGUIDE® DCYL Cylindrical DiffuserPinnacle Biologics, Inc.MVG2014-09-16
00376128000124OPTIGUIDE® DCYL Cylindrical DiffuserPinnacle Biologics, Inc.MVG2014-09-16
00376128000131OPTIGUIDE® DCYL Cylindrical DiffuserPinnacle Biologics, Inc.MVG2014-09-16
00376128000148OPTIGUIDE® DCYL Cylindrical DiffuserPinnacle Biologics, Inc.MVG2014-09-16