Lumicell Direct Visualization System (DVS)

Basic Information

• Brand Name: Lumicell Direct Visualization System (DVS)
• Primary DI: 00860003252550
• Version / Model: 810-00211
• Catalog Number: 810-00211
• Company Name: Lumicell, Inc.
• Labeler DUNS: 832329788
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-19
• Public Version: 1
• Public Version Date: 2024-11-27
• Public Version Status: New
• Public Device Record Key: 6b6a5258-cd85-45bb-846a-94274b17025f

Device Description

Handheld Probe

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Hydrogen Peroxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SAW	Fluorescence Imaging For Breast Cancer Detection	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
67342	Intraoperative tumour margin fluorescence imaging system probe	An electronic component of an intraoperative tumour margin fluorescence imaging system designed for the excitation of an injected fluorophore (e.g., pegulicianine), and subsequent imaging of the illuminated area, to allow for intraoperative detection of residual cancerous tissue in the resection cavity following removal of the primary specimen during surgical procedure (e.g., lumpectomy). It includes a handpiece with an optical component including a digital camera which is inserted into the cavity for image capture, and a cable which includes a connection to the computerised system and a fibre optic light guide. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003252550	GS1
Package	00860003252581	GS1		1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P230014	000

Device Sizes

Type	Value	Unit	Text
Length	1.28	Inch

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 41 – 122 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 41 – 82.4 Degrees Fahrenheit