← Back to catalogue
microTargeting™ Single Electrode Insertion Tube Set
FDA UDIClass II (US FDA UDI)
by Fhc, Inc.
Identity
- Trade Name
- microTargeting™ Single Electrode Insertion Tube Set FDA UDI
- Generic Name
- Intracerebral cannula, implantable FDA UDI
- Device Name
- microTargeting™ Single Electrode Insertion Tube Set, 15mm above target, for use with Nexframe and Nexdrive 1X Contains: IT(DB2): Insertion Tube - 196.6mm tube length, 1.83mm od, 1.6mm id PT(DB3): Protective Tube - 0.58mm id SA8-24-08: Spacer Cleaning Tool - 215mm length FDA UDI
- Model / Reference
- 66-IT-4015N-00621 FDA UDI
- Description
- microTargeting™ Single Electrode Insertion Tube Set, 15mm above target, for use with Nexframe and Nexdrive 1X Contains: IT(DB2): Insertion Tube - 196.6mm tube length, 1.83mm od, 1.6mm id PT(DB3): Protective Tube - 0.58mm id SA8-24-08: Spacer Cleaning Tool - 215mm length FDA UDI
Identifiers
- Catalog Number
- 66-IT-4015N FDA UDI
- Primary DI / UDI-DI
- 00873263006214 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
- 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 — 15 Millimeter FDA UDI
Category: Intracerebral cannula, implantable
microTargeting™ Single Electrode Insertion Tube Set by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracerebral cannula, implantable.
- Cannula — Alpha Omega Engineering Corp. · Class II
- Cannula — Alpha Omega Engineering Corp. · Class II
- Cannula — Alpha Omega Engineering Corp. · Class II
- Cannula — Alpha Omega Engineering Corp. · Class II
- Cannula — Alpha Omega Engineering Corp. · Class II
- Cannula — Alpha Omega Engineering Corp. · Class II
- Cannula — Alpha Omega Engineering Corp. · Class II
- Cannula — Alpha Omega Engineering Corp. · 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 b58ab2ee-8505-4918-a156-bc1415da95b7 38 fields · synced May 31, 2026