Schanz Screw 4x120mm, 10 pack w/o CE

GUDID 07290115752908

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable

Primary Device ID	07290115752908
NIH Device Record Key	ad772da1-cd70-4554-95d9-d358d874006d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Schanz Screw 4x120mm, 10 pack w/o CE
Version Model Number	KIT0001798-01
Company DUNS	532681590
Company Name	MAZOR ROBOTICS LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290115752908 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K203005

FDA Product Code

OLO	Orthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[07290115752908]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-04-10
Device Publish Date	2023-03-31

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07290115752441 - 10.5 Arm Guide KIT	2024-08-12
07290115752458 - 10.5 Arm Guide Screw Kit	2024-08-12
07290115752816 - Short Drill Guide and Short Cannula	2024-08-12

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