Identity
- Trade Name
- microTargeting™ Insertion Tube FDA UDI
- Generic Name
- Intracerebral cannula, nonimplantable, reusable FDA UDI
- Device Name
- microTargeting Insertion Tube with Stylet, nonsterile FDA UDI
- Model / Reference
- 66-IT(IT1)-00697 FDA UDI
- Description
- microTargeting Insertion Tube with Stylet, nonsterile FDA UDI
Identifiers
- Catalog Number
- 66-IT(IT1) FDA UDI
- Primary DI / UDI-DI
- 00873263006979 FDA UDI
- 510(k) Number
- K011775 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Intracerebral cannula, nonimplantable, reusable 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 189 Millimeter FDA UDIOuter Diameter — 1.8 Millimeter FDA UDILumen/Inner Diameter — 1.5 Millimeter FDA UDI
Category: Intracerebral cannula, nonimplantable, reusable
microTargeting™ Insertion Tube by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracerebral cannula, nonimplantable, reusable.
- CODMAN® — Integra LifeSciences Production Corporation · Class I
- CODMAN® — Integra LifeSciences Production Corporation · Class I
- CODMAN® — Integra LifeSciences Production Corporation · Class II
- CODMAN® — Integra LifeSciences Production Corporation · Class I
- CODMAN® — Integra LifeSciences Production Corporation · Class I
- CODMAN® — Integra LifeSciences Production Corporation · Class I
- CODMAN® — Integra LifeSciences Production Corporation · Class I
- V. Mueller — STERIS CORPORATION · Class I
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 |
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Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (1)
- FDA UDI d65dcec8-4155-43c8-97d8-b7836750e952 38 fields · synced May 30, 2026