ROSA ONE SURGICAL ASSISTANT (US) ROSAS00203

GUDID 00887868585951

Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B

MEDTECH

Multi-purpose stereotactic surgery system
Primary Device ID00887868585951
NIH Device Record Key90addd5d-94da-4214-a022-70342b09389d
Commercial Distribution StatusIn Commercial Distribution
Brand NameROSA ONE SURGICAL ASSISTANT (US)
Version Model Number3.1.7
Catalog NumberROSAS00203
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
GS100887868585951 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-10-24
Device Publish Date2022-06-20

On-Brand Devices [ROSA ONE SURGICAL ASSISTANT (US)]

03760244034793Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, sup
00887868585951Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, sup

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