2D X-RAY LEKSELL FRAME REGST PLATES ROSAS00345

GUDID 03760244031044

2D X-RAY LEKSELL FRAME REGISTRATION PLATES instrument Rosa One 3.1 (brain application) calibrated tool for manual registration of the device with the Leksell frame. Mounted on the Leksell stereotactic frame."

MEDTECH

Multi-purpose stereotactic surgery system
Primary Device ID03760244031044
NIH Device Record Keyc1d8d418-9d48-4fa3-b4bf-e36ec732cd38
Commercial Distribution StatusIn Commercial Distribution
Brand Name2D X-RAY LEKSELL FRAME REGST PLATES
Version Model Number174015
Catalog NumberROSAS00345
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
GS103760244031044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


[03760244031044]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-10-02
Device Publish Date2019-07-27

Devices Manufactured by MEDTECH

00889024671102 - PLANNING STATION - ROSA ONE - USA2024-05-28 Planning Station DELL 7520 Qwerty power plug B for Rosa One
00887868540028 - ROBOT ARM INTERFACE2024-02-28 Robot Arm Interface ROSA One
00889024663282 - PLANNING STATION - ROSA ONE - USA2024-02-28 Planning station DELL 3580 Qwerty power plug B for Rosa One 3.1.7
03760244031129 - Trnsnsl Endscp Ovoid Ø6.18mm Holder2023-11-06 Trnsnsl Endscp Ovoid Ø6.18mm Holder instrument Rosa 3.1 (Brain application) instrument holder for guidance of a Storz sheath 72
00887868585951 - ROSA ONE SURGICAL ASSISTANT (US)2023-10-24 Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B
03760244034793 - ROSA ONE SURGICAL ASSISTANT (US)2022-06-28 Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B
03760244034922 - PLANNING STATION-ROSA ONE- USA2022-06-28 planning station DELL 3560 Querty power plug B for Rosa One 3.1.6
03760244035127 - PLANNING STATION-ROSA ONE- USA2022-06-28 planning station DELL 3560 QUERTY power plug B for Rosa One 3.1.5

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