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microTargeting™ Drive Accessories Kit
FDA UDIClass II (US FDA UDI)
by Fhc, Inc.
Identity
- Trade Name
- microTargeting™ Drive Accessories Kit FDA UDI
- Generic Name
- Neurosurgical micro targeting drive FDA UDI
- Device Name
- Accessories kit for microTargeting(TM) Drive Contains: 2, .5" Thumbknob 2, .75" Thumbknob 1, .375" Thumbknob 4, #4-40, 1/8" set screw 2, #6-32, 1/8" set screw FDA UDI
- Model / Reference
- 66-AC-KT-00491 FDA UDI
- Description
- Accessories kit for microTargeting(TM) Drive Contains: 2, .5" Thumbknob 2, .75" Thumbknob 1, .375" Thumbknob 4, #4-40, 1/8" set screw 2, #6-32, 1/8" set screw FDA UDI
Identifiers
- Catalog Number
- 66-AC-KT FDA UDI
- Primary DI / UDI-DI
- 00873263004913 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
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Neurosurgical micro targeting drive
microTargeting™ Drive Accessories Kit by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurosurgical micro targeting drive.
- microTargeting™ Drive DBS Adapter — FHC, INC. · Class II
- microTargeting™ Array Electrode Carrier and Clamp — FHC, INC. · Class II
- MacroStim Interface (MSI) — FHC, INC. · Class II
- microTargeting™ Directional Lead Holder — FHC, INC. · Class II
- STar™ Drive Frame Adapter — FHC, INC. · Class II
- microTargeting™ Matrix Guide Bushings — FHC, INC. · Class II
- STar™ Drive Frame Adapter — FHC, INC. · Class II
- microTargeting™ Controller — FHC, INC. · Class II
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 5cda30cd-dd72-482f-a48b-7d4e1066d35d 37 fields · synced May 30, 2026