VENTRICULAR ENDOSCOPY INSTRUMENT HOLDER ROSAS00351

GUDID 03760244031952

"VENTRICULAR ENDOSCOPY INSTRUMENT HOLDER instrument Rosa One 3.1 (brain application) instrument holder for guidance of neurosurgical endoscope during ventricular procedures through instrument adaptors to accomodate specific endoscope models, positionned by the robot arm in accordance with pre-operative plan."

MEDTECH

Multi-purpose stereotactic surgery system

Primary Device ID	03760244031952
NIH Device Record Key	b3d851a4-a68a-4d75-b3fd-7781d8e38db6
Commercial Distribution Status	In Commercial Distribution
Brand Name	VENTRICULAR ENDOSCOPY INSTRUMENT HOLDER
Version Model Number	174114-01
Catalog Number	ROSAS00351
Company DUNS	264502977
Company Name	MEDTECH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-800-348-2759
Email	product.experience@zimmerbiomet.com
Phone	1-800-348-2759
Email	product.experience@zimmerbiomet.com
Phone	1-800-348-2759
Email	product.experience@zimmerbiomet.com
Phone	1-800-348-2759
Email	product.experience@zimmerbiomet.com
Phone	1-800-348-2759
Email	product.experience@zimmerbiomet.com
Phone	1-800-348-2759
Email	product.experience@zimmerbiomet.com
Phone	1-800-348-2759
Email	product.experience@zimmerbiomet.com
Phone	1-800-348-2759
Email	product.experience@zimmerbiomet.com
Phone	1-800-348-2759
Email	product.experience@zimmerbiomet.com
Phone	1-800-348-2759
Email	product.experience@zimmerbiomet.com
Phone	1-800-348-2759
Email	product.experience@zimmerbiomet.com
Phone	1-800-348-2759
Email	product.experience@zimmerbiomet.com
Phone	1-800-348-2759
Email	product.experience@zimmerbiomet.com
Phone	1-800-348-2759
Email	product.experience@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760244031952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182417

FDA Product Code

HAW	Neurological Stereotaxic Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[03760244031952]

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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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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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

[03760244031952]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-07-24
Device Publish Date	2020-06-02

On-Brand Devices [VENTRICULAR ENDOSCOPY INSTRUMENT HOLDER]

03760244031402	VENTRICULAR ENDOSCOPY INSTRUMENT HOLDER instrument Rosa 3.0 instrument Rosa 3.1 instrument holde
03760244031952	"VENTRICULAR ENDOSCOPY INSTRUMENT HOLDER instrument Rosa One 3.1 (brain application) instrument

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