Identity
- Trade Name
- MAYFIELD HEAD HOLDER ADAPTOR FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- Mayfield Head Holder Adaptor instrument Rosa One 3.1 (brain application) Mayfiled head holder mechanical adaptor to connect the support arm to a mayfiled head holder FDA UDI
- Model / Reference
- 174013-00 FDA UDI174013-01 FDA UDI
- Description
- Mayfield Head Holder Adaptor instrument Rosa One 3.1 (brain application) Mayfiled head holder mechanical adaptor to connect the support arm to a mayfiled head holder FDA UDI
Identifiers
- Catalog Number
- ROSAS00325 FDA UDI
- Primary DI / UDI-DI
- 03760244032119 FDA UDI03760244034052 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
Mayfield Head Holder Adaptor 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
K200511 also covers:
- CRW frame adaptor — MEDTECH LLC
- LEKSELL FRAME REGISTRATION PLATES — MEDTECH LLC
- LEKSELL FRAME REGISTRATION PLATES — 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
- 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 (2)
- FDA UDI c836be9a-12f2-42e2-abbb-8f03ffa1b4dc 35 fields · synced May 31, 2026
- FDA UDI ea5263dc-4d13-4db0-a225-4c2fcdd61ca4 36 fields · synced May 27, 2026