Identity
- Trade Name
- Optical distance sensor FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- OPTICAL DISTANCE SENSOR (V3) instrument Rosa One 3.1 (brain application) Optical distance sensor for contactless location of anatomical structures or landmarks. Used for markerless automatic registration and free-hand navigation FDA UDI
- Model / Reference
- 174007 FDA UDI
- Description
- OPTICAL DISTANCE SENSOR (V3) instrument Rosa One 3.1 (brain application) Optical distance sensor for contactless location of anatomical structures or landmarks. Used for markerless automatic registration and free-hand navigation FDA UDI
Identifiers
- Catalog Number
- ROSAS00316 FDA UDI
- Primary DI / UDI-DI
- 03760244032195 FDA UDI
- FDA Product Code
- 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
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
Optical distance sensor by Medtech Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- PLANNING STATION Rosa One — MEDTECH LLC
- PLANNING STATION Rosa One -USA — MEDTECH LLC
- ROBOT 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
K231103 also covers:
- ALLEN WRENCH 8MM — MEDTECH LLC
- CRW frame adaptor — MEDTECH LLC
- LEKSELL FRAME REGISTRATION PLATES — MEDTECH LLC
- PLANNING STATION - ROSA ONE - USA — MEDTECH LLC
- PLANNING STATION - ROSA ONE - USA — MEDTECH LLC
- ROSA ONE BRAIN APPLICATION (US) — MEDTECH LLC
- Radiolucent support arm — MEDTECH LLC
- SEEG DRILL ADAPTOR 2.70MM — MEDTECH LLC
- TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 3, 9 mm — MEDTECH LLC
- TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 5, 1 mm — MEDTECH LLC
- Trnsnsl Endscp Ovoid Ø6.18mm Holder — 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 |
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Manufacturer
- Manufacturer
- Medtech Llc
Sources (1)
- FDA UDI 2b3564c1-af87-477e-bab6-69593621b8e1 36 fields · synced May 30, 2026