AccessGUDID - DEVICE: Lumicell Direct Visualization System (DVS) (00860003252543)

GUDID

Device Identifier (DI) Information

Brand Name: Lumicell Direct Visualization System (DVS)
Version or Model: 810-00217
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lumicell, Inc.

Primary DI Number: 00860003252543
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832329788 *Terms of Use

Device Description: Workstation Assembly

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?
67341	Intraoperative tumour margin fluorescence imaging system	An electrically-powered fluorescence imaging device assembly intended to be used during surgery for the excitation of an injected fluorophore (e.g., pegulicianine) to enable intraoperative detection of residual cancerous tissue in the resection cavity following removal of the primary specimen during a surgical procedure (e.g., lumpectomy). It is a software-operated system typically consisting of a computer with a display and controls, a light source and handheld excitation probe with a camera for image capture. It is designed to illuminate residual cancerous tissue to facilitate image-guided surgery.	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: No

Sterilization Method [?]
No Sterilization Methods Found

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: ee401f3b-4085-496a-a4d9-ee55c387993d
Public Version Date: November 27, 2024
Public Version Number: 1
DI Record Publish Date: November 19, 2024