Identity
- Trade Name
- microTargeting™ Insertion Tube FDA UDI
- Generic Name
- Intracerebral cannula, implantable FDA UDI
- Device Name
- microTargeting Lead Insertion Tube with Stylet, 5x, Sterile, Array for use with NexFrame and mT Drive. FDA UDI
- Model / Reference
- FC7140LI-00118 FDA UDI
- Description
- microTargeting Lead Insertion Tube with Stylet, 5x, Sterile, Array for use with NexFrame and mT Drive. FDA UDI
Identifiers
- Catalog Number
- FC7140LI FDA UDI
- Primary DI / UDI-DI
- 10873263001186 FDA UDI
- 510(k) Number
- K011775 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Intracerebral cannula, implantable 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 225.35 Millimeter FDA UDIOuter Diameter — 1.83 Millimeter FDA UDILumen/Inner Diameter — 1.6 Millimeter FDA UDI
A medical device that uses a microTargeting Lead Insertion Tube with Stylet, 5x, Sterile, Array for use with NexFrame and mT Drive. This device is designed to be implanted in the brain to guide deep brain electrical stimulation leads/electrodes.
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 638144d4-ac23-449e-ab08-fafe2fd26e0d 39 fields · synced Jul 21, 2026