Identity
- Trade Name
- Spiral Fetal Scalp Electrode FDA UDI
- Generic Name
- Foetal scalp electrode, spiral FDA UDI
- Device Name
- Spiral Fetal Scalp Electrode FDA UDI
- Model / Reference
- CNS000004 FDA UDI
- Description
- Spiral Fetal Scalp Electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247020505 FDA UDI
- 510(k) Number
- K030691 FDA UDI
- FDA Product Code
- HGP FDA UDI
- GMDN Term
- Foetal scalp electrode, spiral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2675 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
Yes
FDA UDI
Category: Foetal scalp electrode, spiral
Spiral Fetal Scalp Electrode by Clinical Innovations, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Foetal scalp electrode, spiral.
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- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Kendall — Cardinalhealth · Class II
- Kendall — Cardinal Health 200, LLC · Class II
Cleared under the same submission
K030691 also covers:
- FSE Cables — Clinical Innovations, LLC
- FSE Cables — Clinical Innovations, LLC
- FSE Cables — Clinical Innovations, LLC
- FSE Cables — Clinical Innovations, LLC
- FSE Cables — Clinical Innovations, LLC
- FSE Cables — Clinical Innovations, LLC
- FSE Cables — Clinical Innovations, LLC
- FSE Cables — Clinical Innovations, LLC
- FSE Cables — Clinical Innovations, LLC
- Goldtrace One — Clinical Innovations, LLC
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
- Clinical Innovations, LLC
Sources (1)
- FDA UDI ce33a51a-b13a-433e-ba89-d5179318f254 34 fields · synced Jun 9, 2026