FDA.report

INFRARED 800 with FLOW® 800 Option

Primary DI
04049539102362
Brand
INFRARED 800 with FLOW® 800 Option
Company
Carl Zeiss Meditec AG
Model
302581-9245-000 302581-9250-000 302581-9246-000
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IZISystem, X-Ray, Angiographic

Product Code Classifications

CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2

Premarket Submissions

SubmissionSupplement
K100468000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K100468000ZEISS INFRARED 800 WITH FLOW 800 OPTIONCarl Zeiss Surgical GmbH2010-03-03IZI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049539102362PrimaryGS10

GMDN Terms

TermDefinition
Surgical microscope fluorescent angiography systemA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
342228620
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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