Identity
- Trade Name
- microTargeting™ Drive System FDA UDI
- Generic Name
- Neurosurgical micro targeting drive FDA UDI
- Device Name
- microTargeting Drive System Contains: -microTargeting Manual Drive -Drive Mount and Guide -microTargeting(TM) Sterilization Case -Verfication Probe -DBS Measurement Fixture -DBS Adapter for microTargeting(TM) Drive - Accessories kit -Matrix Guide Bushings -Lumen Cleaning Tool FDA UDI
- Model / Reference
- MT-DS-00352 FDA UDI
- Description
- microTargeting Drive System Contains: -microTargeting Manual Drive -Drive Mount and Guide -microTargeting(TM) Sterilization Case -Verfication Probe -DBS Measurement Fixture -DBS Adapter for microTargeting(TM) Drive - Accessories kit -Matrix Guide Bushings -Lumen Cleaning Tool FDA UDI
Identifiers
- Catalog Number
- MT-DS FDA UDI
- Primary DI / UDI-DI
- 00873263003527 FDA UDI
- 510(k) Number
- K011775 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neurosurgical micro targeting drive
microTargeting™ Drive System 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
K011775 also covers:
- 33 cm Lead Insertion Tube Set — FHC, INC.
- Microtargeting ™ STar Drive Adapter — FHC, INC.
- STar™ Drive Insertion Tube Extractor — FHC, INC.
- microTargeting Insertion Tube — FHC, INC.
- microTargeting™ Array Electrode Carrier and Clamp — FHC, INC.
- microTargeting™ Electrode and Insertion Tube — FHC, INC.
- microTargeting™ Frame Adapter — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (1)
- FDA UDI 6a351965-9d68-42e1-86da-3862ce12a8fa 37 fields · synced May 30, 2026