OPTICAL DISTANCE SENSOR ROSAS00316

GUDID 03760244031150

OPTICAL DISTANCE SENSOR (V3) instrument Rosa 3.0 Optical distance sensor for contactless location of anatomical structures or landmarks. Used for markerless automatic registration and free-hand navigation

MEDTECH

Multi-purpose stereotactic surgery system
Primary Device ID03760244031150
NIH Device Record Key6e8fc4d6-d63c-431e-a5b9-f5caf682a78e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPTICAL DISTANCE SENSOR
Version Model NumberROSA3-277B
Catalog NumberROSAS00316
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
GS103760244031150 [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 Number3
Public Version Date2019-05-03
Device Publish Date2016-10-09

On-Brand Devices [OPTICAL DISTANCE SENSOR]

03760244031150OPTICAL DISTANCE SENSOR (V3) instrument Rosa 3.0 Optical distance sensor for contactless locatio
03760244032195OPTICAL DISTANCE SENSOR (V3) instrument Rosa One 3.1 (brain application) Optical distance sensor

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