FDA.reportPublic FDA data

OPTIGUIDE® DCYL Cylindrical Diffuser

Primary DI
00376128000087
Brand
OPTIGUIDE® DCYL Cylindrical Diffuser
Company
Pinnacle Biologics, Inc.
Model
210
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).
Published
2014-09-16
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
P940010000
P940010001
P940010002
P940010003
P940010004
P940010005
P940010006
P940010007
P940010008
P940010009
P940010010
P940010012
P940010014

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P940010000OPTIGUIDE(TM) FIBER OPTIC DIFFUSERPinnacle Biologics, Inc.1995-12-27MVG
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
P940010012OPTIGUIDE(TM) FIBER OPTIC DIFFUSERPinnacle Biologics, Inc.1995-12-27MVG
P940010014OPTIGUIDE(TM) FIBER OPTIC DIFFUSERPinnacle Biologics, Inc.1995-12-27MVG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00376128000087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00376128000087003761280000873761280000870376128000087

GMDN Terms#

Term, Definition table
TermDefinition
Laser beam delivery unit, fibreopticA flexible fibreoptic cable intended to be used for the delivery of laser energy of visible and near-infrared wavelengths. It permits the transmission of the laser's output to the target site vicinity. A disposable laser fibre contact probe can be coupled to this for final delivery of the laser beam to the target site. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-248-2039pinnaclemedinfo@optum.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
00376128000254Optiguide® Cylindrical Fiber Optic Diffuser2252019-08-30
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

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
00376128000254Optiguide® 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
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