DEVICE: Lumicell Direct Visualization System (DVS) (00860003252567)

Device Identifier (DI) Information

Lumicell Direct Visualization System (DVS)
810-00214
In Commercial Distribution

Lumicell, Inc.
00860003252567
GS1

1
832329788 *Terms of Use
Calibration Plate, Disposable
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
SAW Fluorescence Imaging For Breast Cancer Detection
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P230014 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ceb38675-0974-44e8-abda-9a538127fbfd
November 27, 2024
1
November 19, 2024
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
1-833-458-6387
support@lumicell.com
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