ROSA PLANNING STATION ROSAS00349

GUDID 03760244031662

ROSA PLANNING STATION (V3) Laptop computer with the following minimal configuration : Windows 7, intel Pentium processor, 15,6'' screen, DVD +/- RW, USB ports, 25GB graphics card, eternet connection for PACS interface with graphical user interface for surgical planning, pre-operative navigation and frameless streotaxy.

MEDTECH

Neurological stereotactic surgery system
Primary Device ID03760244031662
NIH Device Record Keya819ab9e-ecbc-46d8-8df6-4ae5dbab709f
Commercial Distribution Discontinuation2018-04-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameROSA PLANNING STATION
Version Model NumberPrecision 7510
Catalog NumberROSAS00349
Company DUNS264502977
Company NameMEDTECH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS103760244031662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-10-02
Device Publish Date2016-10-09

On-Brand Devices [ROSA PLANNING STATION ]

03760244030375ROSA PLANNING STATION Laptop computer with the following minimal configuration : Windows 7, inte
03760244031662ROSA PLANNING STATION (V3) Laptop computer with the following minimal configuration : Windows 7,
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.