Rosa One Surgical Assistant (us)

FDA UDI

Class II (US FDA UDI)

by Medtech Llc

Identity

Trade Name: ROSA ONE SURGICAL ASSISTANT (US) FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B FDA UDI
Model / Reference: 3.1.6 FDA UDI
Description: Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B FDA UDI

Identifiers

Catalog Number: ROSAS00203 FDA UDI
Primary DI / UDI-DI: 03760244034793 FDA UDI
FDA Product Code: OLO FDA UDI
HAW FDA UDI
GMDN Term: Multi-purpose stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Multi-purpose stereotactic surgery system

Rosa One Surgical Assistant (us) by Medtech Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtech Llc

Sources (1)

FDA UDI 90addd5d-94da-4214-a022-70342b09389d 34 fields · synced May 30, 2026