Identity
- Trade Name
- microTargeting™ Electrode FDA UDI
- Generic Name
- Depth electrode FDA UDI
- Device Name
- microTargeting(TM) Electrode, sterile, D.ZAP(Z), for use with Nexframe(R) FDA UDI
- Model / Reference
- 5005Z-00277 FDA UDI
- Description
- microTargeting(TM) Electrode, sterile, D.ZAP(Z), for use with Nexframe(R) FDA UDI
Identifiers
- Catalog Number
- 5005Z FDA UDI
- Primary DI / UDI-DI
- 00873263002773 FDA UDI
- 510(k) Number
- K033173 FDA UDI
- FDA Product Code
- GZL FDA UDI
- GMDN Term
- Depth electrode 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
Yes
FDA UDI
Single Use
Yes
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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 234.2 Millimeter FDA UDILength — 10 Millimeter FDA UDILength — 249.2 Millimeter FDA UDIOuter Diameter — 0.56 Millimeter FDA UDI
Category: Depth electrode
microTargeting™ Electrode by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 cc2e3bed-ed90-49c9-90ce-3df93e1c3bc3 38 fields · synced May 30, 2026