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TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 5, 1 mm
FDA UDIClass II (US FDA UDI)
by Medtech Llc
Identity
- Trade Name
- TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 5,1 mm FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- Trnsnsl Endscp Rnd Ø5.1mm Holder Instrument ROSA One 3.1 (brain application) Instrument holder for guidance an endoscope during endonasal procedures. Positioned by the robot arm in accordance with a pre-operative plan. FDA UDI
- Model / Reference
- 174040-01 FDA UDI
- Description
- Trnsnsl Endscp Rnd Ø5.1mm Holder Instrument ROSA One 3.1 (brain application) Instrument holder for guidance an endoscope during endonasal procedures. Positioned by the robot arm in accordance with a pre-operative plan. FDA UDI
Identifiers
- Catalog Number
- ROSAS00320 FDA UDI
- Primary DI / UDI-DI
- 03760244032294 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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Multi-purpose stereotactic surgery system
TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 5, 1 mm 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
- Optical distance sensor — 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
K231103 also covers:
- ALLEN WRENCH 8MM — MEDTECH LLC
- CRW frame adaptor — MEDTECH LLC
- LEKSELL FRAME REGISTRATION PLATES — MEDTECH LLC
- Optical distance sensor — 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
- 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 c82ae4fd-ce9e-404b-b7b1-fa4e39176469 36 fields · synced Jun 8, 2026