Identity
- Trade Name
- microTargeting™ Spacer Tube FDA UDI
- Generic Name
- Intracerebral cannula, nonimplantable, reusable FDA UDI
- Device Name
- microTargeting™ Spacer Tube, nonsterile, for use with 66-IT(IT1) FDA UDI
- Model / Reference
- 66-PT(IT1)-00698 FDA UDI
- Description
- microTargeting™ Spacer Tube, nonsterile, for use with 66-IT(IT1) FDA UDI
Identifiers
- Catalog Number
- 66-PT(IT1) FDA UDI
- Primary DI / UDI-DI
- 00873263006986 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
- Lumen/Inner Diameter — 1 Millimeter FDA UDILength — 192 Millimeter FDA UDIOuter Diameter — 1.5 Millimeter FDA UDI
Category: Intracerebral cannula, nonimplantable, reusable
microTargeting™ Spacer 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 818787e0-71cc-4509-bebf-44f9430a3265 38 fields · synced May 31, 2026