FDA.reportPublic FDA data

5.5/6.0 Arm Guide Kit

Primary DI
07290109183923
Brand
5.5/6.0 Arm Guide Kit
Company
MAZOR ROBOTICS LTD
Model
MAS2658-04
Catalog number
KIT0897-03
Published
2020-01-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109183923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109183923072901091839237290109183923

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic surgery system probe, reusableA long, slender, rod-like device made of metal, used during image guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip to that of a targeted tissue of interest within a patient so that this area of tissue is clearly pinpointed with respect to diagnostic images stored in the stereotactic surgery system. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+97246187100info@mazorrobotics.com

Regulatory Flags#

DUNS number
532681590
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109184074BranchMAS2637-01MAS2637-01S2020-04-22
07290109184142360° BridgeMAS2313-01MAS2313-01S2020-04-22
07290109184159Bridge AdaptorMAS2382-01MAS2382-01S2020-04-22
07290109184166Bridge LockMAS2383-01MAS2383-01S2020-04-22
07290109184173MIST BridgeMAS2438-01MAS2438-01S2020-04-22
07290109184180Radiolucent MIS ClampMAS2480-01MAS2480-01S2020-04-22
07290109184197Tall ClampMAS2608-01MAS2608-01S2020-04-22
07290109184203Short ClampMAS2609-01MAS2609-01S2020-04-22
07290109184210Standard BridgeMAS2638-01MAS2638-01S2020-04-22
07290109184227Short BranchMAS2643-01MAS2643-01S2020-04-22
07290109183886StarDriver KitMAS2536-04KIT0893-032020-01-14
072901091838934.75 Arm Guide Screw KitMSA2654-03KIT0893-032020-01-14
072901091839094.75 Arm Guide KITMAS2655-04KIT0895-032020-01-14
072901091839165.5/6.0 Arm Guide Screw KitMAS2656-03KIT0896-032020-01-14
07290109183930Snapshot Tracker Kit MAS2659-03KIT0898-032020-01-14
07290109183947Robotic Frame Connection KitMAS2662-03KIT0899-032020-01-14
07290109183619StarDriver KitMAS2536-03KIT0893-022019-10-03
072901091836264.75 Arm Guide Screw KitMAS2654-02KIT0894-022019-10-03
072901091836334.75 Arm Guide KitMAS2655-03KIT0895-022019-10-03
072901091836405.5/6.0 Arm Guide Screw KitMAS2656-02KIT0896-022019-10-03

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