Target Extender KIT2847-01

GUDID 07290109183824

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable

Primary Device ID	07290109183824
NIH Device Record Key	beddeb56-61da-4848-bc6f-e586bd8f7107
Commercial Distribution Status	In Commercial Distribution
Brand Name	Target Extender
Version Model Number	MAS2847-01
Catalog Number	KIT2847-01
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	07290109183824 [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

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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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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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[07290109183824]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-03-22
Device Publish Date	2021-03-14

On-Brand Devices [Target Extender]

07290109181615	MAS2310-04
07290109183824	MAS2847-01
07290115750485	MAS2310-05S
07290115751710	MAS2310-06S

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