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OPTIGUIDE® DCYL Cylindrical Diffuser

FDA UDI

Class III (US FDA UDI)

by Pinnacle Biologics, Inc.

Identity

Trade Name
OPTIGUIDE® DCYL Cylindrical Diffuser FDA UDI
Generic Name
Gastrointestinal photodynamic therapy laser beam guide FDA UDI
Device Name
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). FDA UDI
Model / Reference
220 FDA UDI
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). FDA UDI

Identifiers

Primary DI / UDI-DI
00376128000100 FDA UDI
PMA Number
P940010 FDA UDI
FDA Product Code
MVG FDA UDI
GMDN Term
Gastrointestinal photodynamic therapy laser beam guide FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 2.0 Centimeter FDA UDI

Category: Gastrointestinal photodynamic therapy laser beam guide

OPTIGUIDE® DCYL Cylindrical Diffuser by Pinnacle Biologics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal photodynamic therapy laser beam guide.

Cleared under the same submission

P940010 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pinnacle Biologics, Inc.

Sources (1)

  • FDA UDI 1397a0a1-1ff4-4553-b55c-6865f596d807 36 fields · synced Jun 8, 2026