FDA.report

TIVATO® 700

Primary DI
04049539066435
Brand
TIVATO® 700
Company
Carl Zeiss Meditec AG
Model
6643
Published
2025-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FSOMicroscope, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
FSOMicroscope, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049539066435PrimaryGS10

GMDN Terms

TermDefinition
General-purpose surgical microscopeA general-purpose, surgical, light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures, e.g., nerves or vessels in the performance of delicate surgical procedures which require high magnification by transmitted light. An operating microscope will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.

Sterilization Methods

Method

Regulatory Flags

DUNS number
342228620
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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04049539106018SMARTDRAPE306030-0000-0002025-01-22
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04049471095111VISUMAXVISUMAX 800 or 095112024-12-13
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00811608019772Mounting Kit, Takagi OM-9VOLK OPTICAL INC.FSO2025-03-26
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