Lumicell Direct Visualization System (DVS)

Primary DI
00860008537898
Brand
Lumicell Direct Visualization System (DVS)
Company
Lumicell, Inc.
Model
900-00209
Device description
Sterilization Tray
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
00860008537898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008537898008600085378988600085378980860008537898

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable 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 Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

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
Sterilization required before use
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
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

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
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