DEVICE: Photofrin® 630 PDT Laser (00376128000155)

Device Identifier (DI) Information

Photofrin® 630 PDT Laser
63001
In Commercial Distribution

Pinnacle Biologics, Inc.
00376128000155
GS1

1
833037612 *Terms of Use
630nm Photodynamic Therapy Laser
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Oncological diode laser system A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power [i.e., not considered low-level laser therapy (LLLT)], therapeutic laser beam, typically of visible red-light, intended for oncological photodynamic therapy (PDT) and photochemical internalization (PCI). It is part of a drug-device therapy that combines a pharmaceutical photosensitizer with photoactivation for local cancer treatment. The software-controlled device is designed to deliver cylindrical diffusing outputs and/or frontal diffusing output for surface treatment and/or for interstitial treatment.
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FDA Product Code

[?]
Product Code Product Code Name
MVF System, Laser, Photodynamic Therapy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P990021 003
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Sterilization

No
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
No Device Sizes
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Device Record Status

97207275-94c6-48ad-967a-d34e8e210ab1
July 06, 2018
3
September 19, 2016
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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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
773-312-3723
info@pinnaclebiologics.com
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