UNIV NAV HANDLE ROSAS00187

GUDID 03760244031945

"UNIVERSAL NAVIGATION HANDLE instrument Rosa one 3.1 (spine application) Handle for navigation of neurosurgical instruments"

MEDTECH

Multi-purpose stereotactic surgery system

Primary Device ID	03760244031945
NIH Device Record Key	b702fc18-019d-4219-97ae-07c024121614
Commercial Distribution Status	In Commercial Distribution
Brand Name	UNIV NAV HANDLE
Version Model Number	174066-00
Catalog Number	ROSAS00187
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760244031945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182848

FDA Product Code

OLO	Orthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[03760244031945]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

[03760244031945]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-10-02
Device Publish Date	2020-06-08

On-Brand Devices [UNIV NAV HANDLE]

03760244033628	"UNIVERSAL NAVIGATION HANDLE instrument Rosa one 3.1 (spine application) Handle for navigation o
03760244031945	"UNIVERSAL NAVIGATION HANDLE instrument Rosa one 3.1 (spine application) Handle for navigation o

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