FDA.reportPublic FDA data

Schanz screw 4mmx80

Primary DI
07290109181493
Brand
Schanz screw 4mmx80
Company
MAZOR ROBOTICS LTD
Model
MAS1544-04
Published
2018-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109181493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109181493072901091814937290109181493

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290115752199Mazor X Navigation CameraTPL0063-702025-01-29
07290115752502Surgical System Sleeve,10 PackKIT0953-04 2025-11-20
07290115753462Mazor X Scan & Plan Disposable KitKIT0571-112025-07-11
07290115753479Mazor X Spine Disposable KitKIT0574-132025-07-11
07290115753455Mazor X Guidewire Instruments SetKIT0854-052025-05-07
07290115751307StarDriver KitKIT0893-062025-04-27
072901157513144.75 Arm Guide Screw KitKIT0894-062025-04-27
072901157513214.75 Arm Guide KitKIT0895-062025-04-27
072901157513385.5/6.0 Arm Guide Screw KitKIT0896-062025-04-27
072901157513455.5/6.0 Arm Guide KitKIT0897-062025-04-27
07290115751352Snapshot Tracker KitKIT0898-062025-04-27
07290115751369Robotic Frame Connection KitKIT0899-062025-04-27
07290115751895Mazor X SystemTPL0059-102025-04-27
07290118271925Universal ScrewdriverMAS1650-06S2025-01-30
07290115752755Mazor X Navigation CameraTPL0063-072025-01-22
07290115751215Mazor X Bone Mount CaseMAS2712-02KIT2712-022024-12-30
07290115752229Mazor X Surgical InstrumentsKIT0762-042024-12-30
07290115752236Bridge AdaptorMAS2382-04KIT2382-032024-12-30
07290115752243Bridge LockMAS2383-04KIT2383-032024-12-30
07290115752250Schanz ConnectorMAS2851-03KIT2851-032024-12-30

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Primary DI, Brand, Company table
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