FDA.reportPublic FDA data

Lumicell Direct Visualization System (DVS)

Primary DI
00860003252543
Brand
Lumicell Direct Visualization System (DVS)
Company
Lumicell, Inc.
Model
810-00217
Device description
Workstation Assembly
Published
2024-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SAWFluorescence Imaging For Breast Cancer Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAWFluorescence Imaging For Breast Cancer DetectionUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230014000Lumicell Direct Visualization System (DVS)Lumicell, Inc.2024-04-17SAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008537805PackageGS11In Commercial Distribution
00860003252543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008537805008600085378058600085378050860008537805
00860003252543008600032525438600032525430860003252543

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative tumour margin fluorescence imaging systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit82.4 Degrees Fahrenheit
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature41 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-833-458-6387support@lumicell.com

Regulatory Flags#

DUNS number
832329788
Device count
1
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003252505Lumicell Direct Visualization System (DVS)810-002102024-11-19
00860003252536Lumicell Direct Visualization System (DVS)810-002122024-11-19
00860003252567Lumicell Direct Visualization System (DVS)810-002142024-11-19
00860003252512Lumicell Direct Visualization System (DVS)810-002102024-11-19
00860003252598Lumicell Direct Visualization System (DVS)810-002122024-11-19
00860003252550Lumicell Direct Visualization System (DVS)810-00211810-002112024-11-19
00860008537829Lumicell Direct Visualization System (DVS)810-002142024-11-19
00860008537898Lumicell Direct Visualization System (DVS)900-002092024-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003252505Lumicell Direct Visualization System (DVS)Lumicell, Inc.SAW2024-11-19
00860003252536Lumicell Direct Visualization System (DVS)Lumicell, Inc.SAW2024-11-19
00860003252567Lumicell Direct Visualization System (DVS)Lumicell, Inc.SAW2024-11-19
00860003252512Lumicell Direct Visualization System (DVS)Lumicell, Inc.SAW2024-11-19
00860003252598Lumicell Direct Visualization System (DVS)Lumicell, Inc.SAW2024-11-19
00860003252550Lumicell Direct Visualization System (DVS)Lumicell, Inc.SAW2024-11-19
00860008537829Lumicell Direct Visualization System (DVS)Lumicell, Inc.SAW2024-11-19
00860008537898Lumicell Direct Visualization System (DVS)Lumicell, Inc.SAW2024-11-19