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microTargeting™ Controller with Motor
FDA UDIClass II (US FDA UDI)
by Fhc, Inc.
Identity
- Trade Name
- microTargeting™ Controller with Motor FDA UDI
- Generic Name
- Neurosurgical micro targeting drive FDA UDI
- Device Name
- microTargeting Controller with motor option for use with STar and mT Drives FDA UDI
- Model / Reference
- FC1008-00150 FDA UDI
- Description
- microTargeting Controller with motor option for use with STar and mT Drives FDA UDI
Identifiers
- Catalog Number
- FC1008 FDA UDI
- Primary DI / UDI-DI
- 00873263001509 FDA UDI
- 510(k) Number
- K011992 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Neurosurgical micro targeting drive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- Not 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
microTargeting™ Controller with Motor by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K011992 also covers:
- Electrode Depth Stop Adapter — FHC, INC.
- Frame Adapter for Leibinger RM™ — FHC, INC.
- LeadLoc Depth Stop — FHC, INC.
- LeadLoc Depth Stop — FHC, INC.
- MacroStim Interface (MSI) — FHC, INC.
- microTargeting™ Array Clamp — FHC, INC.
- microTargeting™ Array Electrode Carrier Set — FHC, INC.
- microTargeting™ Cleaning Brushes — FHC, INC.
- microTargeting™ Controller — FHC, INC.
- microTargeting™ Controller — FHC, INC.
- microTargeting™ Controller Handheld Remote Control — FHC, INC.
- microTargeting™ Controller Power Assist System — FHC, INC.
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
- Fhc, Inc.
Sources (1)
- FDA UDI 29596fea-b74e-4e63-bff2-9a59c8913708 38 fields · synced Jun 8, 2026