DEVICE: Lumicell Direct Visualization System (DVS) (00860003252567)
Device Identifier (DI) Information
Lumicell Direct Visualization System (DVS)
810-00214
In Commercial Distribution
Lumicell, Inc.
810-00214
In Commercial Distribution
Lumicell, Inc.
Calibration Plate, Disposable
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
Yes | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
SAW | Fluorescence Imaging For Breast Cancer Detection |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P230014 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between 41 and 122 Degrees Fahrenheit |
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity |
Handling Environment Temperature: between 41 and 82.4 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ceb38675-0974-44e8-abda-9a538127fbfd
November 27, 2024
1
November 19, 2024
November 27, 2024
1
November 19, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00860008537829 | 2 | 10860003252564 | In Commercial Distribution | ||
10860003252564 | 5 | 00860003252567 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-833-458-6387
support@lumicell.com
support@lumicell.com