FDA.reportPublic FDA data

Long drill guide and Long Cannula

Primary DI
07290109184913
Brand
Long drill guide and Long Cannula
Company
MAZOR ROBOTICS LTD
Model
KIT0736-04
Published
2021-02-28
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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200935000
K203005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200935000Mazor XMazor Robotics , Ltd.2020-05-08OLO
K203005000Mazor XMazor Robotics , Ltd.2020-10-27OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109184913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109184913072901091849137290109184913

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic surgery system probe, reusableA slender, rod-like, hand-held manual surgical instrument intended for use 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 with that of a targeted tissue of interest in a patient so the tissue area is precisely identified with respect to diagnostic images stored in the stereotactic surgery system. It is made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
07290115751963Surgeon's Screen Sterile Sleeve,10 packKIT0741-052022-12-18
07290115752212Sterile Clear Sleeve,10 packKIT0742-052022-12-18
07290115751284Mazor X Navigation CameraTPL0063-042022-01-06
07290115752786Mazor X Spine Disposable KitKIT0574-102023-03-31
07290115752878Mazor X Scan & Plan Disposable KitKIT0571-082023-03-31
07290115751291Mazor X Navigation CameraTPL0063-052022-04-15
07290115750867Lateral Optional KitKIT0755-052021-10-21
07290115750737Schanz screw 4mmx80, 10 packKIT0729-052021-08-18
07290115750744Head Pin 2.5x60mm,10 packKIT0731-052021-08-18
07290115750751Auxiliary Drill Guide And Auxiliary CannulaKIT0732-052021-08-18
07290115750768Long Drill 3.0x30, 10 packKIT0733-052021-08-18
07290115750775Short Drill 3x30mm,10 packKIT0734-052021-08-18
07290115750782Long drill 4x80mm,10 packKIT0735-052021-08-18
07290115750799Long drill guide and Long CannulaKIT0736-052021-08-18
07290115750805Short Drill Guide and Short CannulaKIT0737-052021-08-18
07290115750812Long drill 3x80mm,10 packKIT0738-052021-08-18
07290115750829Short Drill 3x80mm,10 packKIT0739-052021-08-18
07290115750836Head Pin 2.5x100mm,10 packKIT0758-052021-08-18
07290115750843Surgeon's screen Sterile Sleeve,10 packKIT0741-042021-08-18
07290115750850Sterile Clear Sleeve,10 packKIT0742-042021-08-18

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