Identity
- Trade Name
- NATUS NEUROLOGY FDA UDI
- Generic Name
- Earphone, insert FDA UDI
- Device Name
- EARPHONE SINGLE (FOR SYNERGY) FDA UDI
- Model / Reference
- 017C146 FDA UDI
- Description
- EARPHONE SINGLE (FOR SYNERGY) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830031431 FDA UDI
- 510(k) Number
- K965065 FDA UDI
- FDA Product Code
- GWF FDA UDI
- GMDN Term
- Earphone, insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1870 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Earphone, insert
Natus Neurology by Natus Neurology Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K965065 also covers:
- NATUS NEUROLOGY — Natus Neurology Incorporated
- NATUS NEUROLOGY — Natus Neurology Incorporated
- NATUS NEUROLOGY — Natus Neurology Incorporated
- NATUS NEUROLOGY — Natus Neurology Incorporated
- NATUS NEUROLOGY — Natus Neurology Incorporated
- NATUS NEUROLOGY — Natus Neurology Incorporated
- NATUS NEUROLOGY — Natus Neurology Incorporated
- NATUS NEUROLOGY — Natus Neurology Incorporated
- NATUS NEUROLOGY — Natus Neurology Incorporated
- NATUS NEUROLOGY — Natus Neurology Incorporated
- NATUS NEUROLOGY — Natus Neurology Incorporated
- NATUS NEUROLOGY — Natus Neurology Incorporated
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
- Natus Neurology Incorporated
Sources (1)
- FDA UDI 92c27a0e-5b9f-46a8-aff3-43487ab17dc8 34 fields · synced Jun 9, 2026