ROSA One

Basic Information

• Brand Name: ROSA One
• Primary DI: 03760244030948
• Version / Model: 3.1.0.5
• Catalog Number: ROSAS00203
• Company Name: MEDTECH
• Labeler DUNS: 264502977
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-07
• Public Version: 4
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 60fd969e-c835-4e31-a7c7-3b8d200595bd
• Distribution End Date: 2019-09-16

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HAW	Neurological Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45199	Multi-purpose stereotactic surgery system	An electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760244030948	GS1

Premarket Submissions

Submission Number	Supplement Number
K182417	000