Identity
- Trade Name
- ROBOT ROSA ONE (USA) 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
- 3.1.5 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
- 03760244034304 FDA UDI
- FDA Product Code
- OLO FDA UDIHAW 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Multi-purpose stereotactic surgery system
Robot Rosa One (usa) by Medtech Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multi-purpose stereotactic surgery system.
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Cleared under the same submission
K192173 also covers:
K200511 also covers:
- CRW frame adaptor — MEDTECH LLC
- LEKSELL FRAME REGISTRATION PLATES — MEDTECH LLC
- LEKSELL FRAME REGISTRATION PLATES — MEDTECH LLC
- MAYFIELD HEAD HOLDER ADAPTOR — MEDTECH LLC
- Optical distance sensor — MEDTECH LLC
- PLANNING STATION Rosa One — MEDTECH LLC
- PLANNING STATION Rosa One -USA — MEDTECH LLC
- ROBOT ROSA ONE (USA) — MEDTECH LLC
- Radiolucent support arm — MEDTECH LLC
- Radiolucent support arm — MEDTECH LLC
- TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 3, 9 mm — MEDTECH LLC
- TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 3, 9 mm — MEDTECH LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtech Llc
Sources (1)
- FDA UDI 6b2d6ce3-8c86-473b-80b7-c4b522e205dd 35 fields · synced May 31, 2026