FDA.reportPublic FDA data

Lumicell Direct Visualization System (DVS)

Primary DI
00860003252512
Brand
Lumicell Direct Visualization System (DVS)
Company
Lumicell, Inc.
Model
810-00210
Device description
Sterile Cover
Published
2024-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
00860003252512PackageGS15In Commercial Distribution
00860008537812PackageGS12In Commercial Distribution
00860003252505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003252512008600032525128600032525120860003252512
00860008537812008600085378128600085378120860008537812
00860003252505008600032525058600032525050860003252505

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative tumour margin fluorescence imaging system probe cover/spacerA polymer sheath intended to be used to cover an intraoperative fluorescence imaging system probe (not included), to create a physical barrier between the patient and the probe, while optimising image acquisition by maintaining an ideal focal distance between the probe tip and the tissue, helping to focus the camera. This is a single-use device.

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 Fahrenheit82.4 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832329788
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00860003252598Lumicell Direct Visualization System (DVS)810-002122024-11-19
00860003252543Lumicell Direct Visualization System (DVS)810-002172024-11-19
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
00860003252598Lumicell Direct Visualization System (DVS)Lumicell, Inc.SAW2024-11-19
00860003252543Lumicell 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