Identity
- Trade Name
- Natus FDA UDI
- Generic Name
- Earphone, insert FDA UDI
- Device Name
- Nicolet TIP 300 ohm Tubal Insert Phone (TIP300) FDA UDI
- Model / Reference
- 041-704000 FDA UDI
- Description
- Nicolet TIP 300 ohm Tubal Insert Phone (TIP300) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830038751 FDA UDI
- 510(k) Number
- K965065 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- GMDN Term
- Earphone, insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1900 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Earphone, insert
Natus by Natus Neurology Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Earphone, insert.
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- E-A-RTONE™ — 3M COMPANY · Class II
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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 ab97251b-d3ee-4cd7-b087-8fc557cd0d7f 34 fields · synced Jun 9, 2026