AccessGUDID - DEVICE: Quest Spectrum Kit for open surgery (08719324487030)

GUDID

Device Identifier (DI) Information

Brand Name: Quest Spectrum Kit for open surgery
Version or Model: ART-ICG-0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Quest Projects B.V.

Primary DI Number: 08719324487030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 386614502 *Terms of Use

Device Description: kit for open surgery: 1x indocyanine Green for injection, USP 25mg vial 1x sterile water for injection, USP 10ml vial 1x1 piece drape art-drp-0-004

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
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?
57883	Surgical microscope fluorescent angiography system	A non-sterile, mains electricity (AC-powered) device assembly designed for viewing intraoperative blood flow in the cerebral vascular area, in bypass grafts during coronary artery bypass graft (CABG) surgery, and during plastic and reconstructive surgery. It enables a surgical microscope to produce excitation light and resolve fluorescence from the fluorescent agent indocyanine green (ICG). Fluorescent signals depict the distribution of the infrared dye in the patient's blood vessels during the operation. The system is attached to a compatible surgical microscope and typically includes an ICG filter, a near infrared (NIR) charge-coupled device (CCD) video camera, and connecting cables.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWN	Confocal Optical Imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4f81fe34-4e75-44b5-ab22-e91de2f4b33c
Public Version Date: March 12, 2020
Public Version Number: 1
DI Record Publish Date: March 04, 2020