AccessGUDID - DEVICE: Leica FL800 ULT (07630003577266)

GUDID

Device Identifier (DI) Information

Brand Name: Leica FL800 ULT
Version or Model: 000000000010448761
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Leica Microsystems (Schweiz) AG

Primary DI Number: 07630003577266
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480198725 *Terms of Use

Device Description: No description.

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:	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
IZI	System, x-ray, angiographic

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -30 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Handling Environment Temperature: between -30 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
Special Storage Condition, Specify:
Handling Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 500 and 1060 millibar

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Not Applicable

Device Record Status

Public Device Record Key: 0a76d5a3-30c1-4c77-ae90-27cc6fdf3aa3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 08, 2016