AccessGUDID - DEVICE: Photofrin® 630 PDT Laser (00376128000155)

GUDID

Device Identifier (DI) Information

Brand Name: Photofrin® 630 PDT Laser
Version or Model: 63001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pinnacle Biologics, Inc.

Primary DI Number: 00376128000155
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 833037612 *Terms of Use

Device Description: 630nm Photodynamic Therapy Laser

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58866	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVF	System, Laser, Photodynamic Therapy

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 97207275-94c6-48ad-967a-d34e8e210ab1
Public Version Date: March 18, 2022
Public Version Number: 5
DI Record Publish Date: September 19, 2016

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

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

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 866-248-2039
Email: productinfo@concordialaboratories.com

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