Optical distance sensor ROSAS00316

GUDID 03760244032195

OPTICAL DISTANCE SENSOR (V3) instrument Rosa One 3.1 (brain application) 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 ID03760244032195
NIH Device Record Key2b3564c1-af87-477e-bab6-69593621b8e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptical distance sensor
Version Model Number174007
Catalog NumberROSAS00316
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 Datefalse
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
GS103760244032195 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-23
Device Publish Date2021-06-15

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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