Lumicell Direct Visualization System (DVS)

Basic Information

• Brand Name: Lumicell Direct Visualization System (DVS)
• Primary DI: 00860003252567
• Version / Model: 810-00214
• 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: ceb38675-0974-44e8-abda-9a538127fbfd

Device Description

Calibration Plate, Disposable

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• 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
67343	Intraoperative tumour margin fluorescence imaging system probe calibrator	A reference standard of known optical and physical characteristics intended to be used to verify and/or optimize the performance of an intraoperative fluorescence tumour margin imaging system probe. It is a double-sided plate (dark/white) designed to be attached to the probe for flat field correction of the excitation light of the imaging system, to ensure accuracy and uniformity of the digital images. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00860008537829	GS1		2	In Commercial Distribution
Package	10860003252564	GS1		5	In Commercial Distribution
Primary	00860003252567	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P230014	000

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