Lumicell Direct Visualization System (DVS)

Basic Information

• Brand Name: Lumicell Direct Visualization System (DVS)
• Primary DI: 00860003252543
• Version / Model: 810-00217
• 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: ee401f3b-4085-496a-a4d9-ee55c387993d

Device Description

Workstation Assembly

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: No

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
67341	Intraoperative tumour margin fluorescence imaging system	An electrically-powered fluorescence imaging device assembly intended to be used during surgery for the excitation of an injected fluorophore (e.g., pegulicianine) to enable intraoperative detection of residual cancerous tissue in the resection cavity following removal of the primary specimen during a surgical procedure (e.g., lumpectomy). It is a software-operated system typically consisting of a computer with a display and controls, a light source and handheld excitation probe with a camera for image capture. It is designed to illuminate residual cancerous tissue to facilitate image-guided surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003252543	GS1
Package	00860008537805	GS1		1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P230014	000

Storage Conditions

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