Identity
- Trade Name
- microTargeting™ Insertion Tube set FDA UDI
- Generic Name
- Intracerebral cannula, nonimplantable, reusable FDA UDI
- Device Name
- microTargeting Single Electrode Insertion Tube Set, 1x, nonsterile Contains: IT(BP13): Insertion Tube - 194mm tube length, 1.83mm od, 1.6mm id PT(BP13): Protective Tube - 1.0mm id 1x Spacer Cleaning tool FDA UDI
- Model / Reference
- 66-IT-13-00813 FDA UDI
- Description
- microTargeting Single Electrode Insertion Tube Set, 1x, nonsterile Contains: IT(BP13): Insertion Tube - 194mm tube length, 1.83mm od, 1.6mm id PT(BP13): Protective Tube - 1.0mm id 1x Spacer Cleaning tool FDA UDI
Identifiers
- Catalog Number
- 66-IT-13 FDA UDI
- Primary DI / UDI-DI
- 00873263008133 FDA UDI
- 510(k) Number
- K033173 FDA UDI
- FDA Product Code
- GZL FDA UDI
- GMDN Term
- Intracerebral cannula, nonimplantable, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1330 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
Category: Intracerebral cannula, nonimplantable, reusable
microTargeting™ 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, nonimplantable, reusable.
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Cleared under the same submission
K033173 also covers:
- Insertion Tube — FHC, INC.
- microTargeting™ Array Electrode — FHC, INC.
- microTargeting™ Array Electrode — FHC, INC.
- microTargeting™ Differential Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — 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 0f36fbf0-c072-4600-a1c6-dc170ebbd08c 37 fields · synced May 30, 2026