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microTargeting™ Guideline 4000 LP+™ Breakout Box
FDA UDIClass II (US FDA UDI)
by Fhc, Inc.
Identity
- Trade Name
- microTargeting™ Guideline 4000 LP+™ Breakout Box FDA UDI
- Generic Name
- Neurophysiologic monitoring system FDA UDI
- Device Name
- microTargeting Guideline 4000 LP+ Breakout Box FDA UDI
- Model / Reference
- MT-LPP-BOX-00279 FDA UDI
- Description
- microTargeting Guideline 4000 LP+ Breakout Box FDA UDI
Identifiers
- Catalog Number
- MT-LPP-BOX FDA UDI
- Primary DI / UDI-DI
- 00873263002797 FDA UDI
- 510(k) Number
- K071364 FDA UDI
- FDA Product Code
- GZL FDA UDI
- GMDN Term
- Neurophysiologic monitoring system 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neurophysiologic monitoring system
microTargeting™ Guideline 4000 LP+™ Breakout Box by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Neurophysiologic monitoring system.
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- NVM5 — Nuvasive, Inc. · Class II
- SafeOp — ALPHATEC SPINE, INC. · Class II
- BIS — Covidien LP · Class II
Cleared under the same submission
K071364 also covers:
- Guideline™ 4000 — FHC, INC.
- Lead Adapter, For use with Multi-Lead Trial Cable to Guideline System — FHC, INC.
- microTargeting ™ Lead Adapter — FHC, INC.
- microTargeting™ Electrode Cable — FHC, INC.
- microTargeting™ Electrode Cable — FHC, INC.
- microTargeting™ Electrode Cable — FHC, INC.
- microTargeting™ Electrode Cable — FHC, INC.
- microTargeting™ Electrode Cable — FHC, INC.
- microTargeting™ Guideline 4000 LP+™ — FHC, INC.
- microTargeting™ Guideline 4000 LP+™ Cart — FHC, INC.
- microTargeting™ Guideline 4000 LP+™ Channel Card — FHC, INC.
- microTargeting™ LP+ Electrode Cable — 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 985370f0-6e5a-4bfd-bcd4-4008d03c2fec 37 fields · synced May 30, 2026