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 ID03760244031945
NIH Device Record Keyb702fc18-019d-4219-97ae-07c024121614
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIV NAV HANDLE
Version Model Number174066-00
Catalog NumberROSAS00187
Company DUNS264502977
Company NameMEDTECH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760244031945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760244031945]

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[03760244031945]

Moist Heat or Steam Sterilization


[03760244031945]

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[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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-10-02
Device Publish Date2020-06-08

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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