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 ID	03760244031044
NIH Device Record Key	c1d8d418-9d48-4fa3-b4bf-e36ec732cd38
Commercial Distribution Status	In Commercial Distribution
Brand Name	2D X-RAY LEKSELL FRAME REGST PLATES
Version Model Number	174015
Catalog Number	ROSAS00345
Company DUNS	264502977
Company Name	MEDTECH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760244031044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182417

FDA Product Code

HAW	Neurological Stereotaxic Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[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 Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-10-02
Device Publish Date	2019-07-27

Devices Manufactured by MEDTECH

00889024671102 - PLANNING STATION - ROSA ONE - USA	2024-05-28 Planning Station DELL 7520 Qwerty power plug B for Rosa One
00887868540028 - ROBOT ARM INTERFACE	2024-02-28 Robot Arm Interface ROSA One
00889024663282 - PLANNING STATION - ROSA ONE - USA	2024-02-28 Planning station DELL 3580 Qwerty power plug B for Rosa One 3.1.7
03760244031129 - Trnsnsl Endscp Ovoid Ø6.18mm Holder	2023-11-06 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- USA	2022-06-28 planning station DELL 3560 Querty power plug B for Rosa One 3.1.6
03760244035127 - PLANNING STATION-ROSA ONE- USA	2022-06-28 planning station DELL 3560 QUERTY power plug B for Rosa One 3.1.5

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