Identity
- Trade Name
- Guideline 4000™ 5.0 FDA UDI
- Generic Name
- Neurophysiologic monitoring system FDA UDI
- Device Name
- MicroTargeting Guidline 4000 5.0 Software 1x FDA UDI
- Model / Reference
- C0217-00679 FDA UDI
- Description
- MicroTargeting Guidline 4000 5.0 Software 1x FDA UDI
Identifiers
- Catalog Number
- C0217 FDA UDI
- Primary DI / UDI-DI
- 00873263006795 FDA UDI
- 510(k) Number
- K183123 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
Yes
FDA UDI
Category: Neurophysiologic monitoring system
Guideline 4000™ 5.0 by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183123 also covers:
- Guideline 4000 5.0™ 3m Interface Cable — FHC, INC.
- Guideline 4000 5.0™ Interface — FHC, INC.
- Guideline 4000 5.0™ LF Interface — FHC, INC.
- Guideline 4000 5.0™ Motor & Encoder — FHC, INC.
- Guideline 4000 5.0™ microTargeting™ Controller Card — FHC, INC.
- Guideline 4000 5.0™ microTargeting™ Interface Card — FHC, INC.
- Guideline 4000™ 5.0 — FHC, INC.
- Guideline 4000™ 5.0 — FHC, INC.
- Guideline 4000™ 5.0 — FHC, INC.
- Guideline 4000™ 5.0 Accessory — FHC, INC.
- Lead Adapter Cable — FHC, INC.
- Resident Expert Kinetic Testing Motion Detector — 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 7d0566fd-0cb9-4c6b-aff1-a14a5df97d99 37 fields · synced Jun 8, 2026