DEVICE: OPTIGUIDE® DCYL Cylindrical Diffuser (00376128000100)

Device Identifier (DI) Information

OPTIGUIDE® DCYL Cylindrical Diffuser
220
In Commercial Distribution

Pinnacle Biologics, Inc.
00376128000100
GS1

1
833037612 *Terms of Use
The DYCL series OPTIGUIDE® Fiber Optic Diffuser is a light delivery system consisting of a 400 μm coated silica laser fiber, a proximal SMA-type laser connector, and a distal light diffusing tip (1.65mm diameter).
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
Yes
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Laser beam delivery unit, fibreoptic A 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.
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FDA Product Code

[?]
Product Code Product Code Name
MVG System, Laser, Fiber Optic, Photodynamic Therapy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P940010 001
P940010 002
P940010 003
P940010 004
P940010 005
P940010 006
P940010 007
P940010 008
P940010 009
P940010 010
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 2.0 Centimeter
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Device Record Status

1397a0a1-1ff4-4553-b55c-6865f596d807
July 06, 2018
3
September 16, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
1-866-248-2039
pinnaclemedinfo@optum.com
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