AccessGUDID - DEVICE: Lumicell Direct Visualization System (DVS) (00860008537898)

GUDID

Device Identifier (DI) Information

Brand Name: Lumicell Direct Visualization System (DVS)
Version or Model: 900-00209
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lumicell, Inc.

Primary DI Number: 00860008537898
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832329788 *Terms of Use

Device Description: Sterilization Tray

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13730	Device sterilization/disinfection container, reusable	A 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.	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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Hydrogen Peroxide

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 41 and 82.4 Degrees Fahrenheit
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 41 and 122 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0c51643d-3cf8-4211-aa63-31c678526d03
Public Version Date: November 27, 2024
Public Version Number: 1
DI Record Publish Date: November 19, 2024