Identity
- Trade Name
- Bio-logic FDA UDI
- Generic Name
- Auditory stimulator FDA UDI
- Device Name
- Standard Insert Earphone, 8 feet cable FDA UDI
- Model / Reference
- Standard Insert Earphone 8 ft FDA UDI
- Description
- Standard Insert Earphone, 8 feet cable FDA UDI
Identifiers
- Catalog Number
- 580-SINSER-008 FDA UDI
- Primary DI / UDI-DI
- 00382830053327 FDA UDI
- 510(k) Number
- K031352 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Auditory stimulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 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
No
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
Dimensions & Sizes
- Size
- Length — 8 Feet FDA UDI
Category: Auditory stimulator
Bio-logic by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Auditory stimulator.
- OAE EarTips — Natus Medical Denmark ApS · Class I
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- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
- Nucleus — Cochlear · Class III
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
- OAE EarTips — Natus Medical Denmark ApS · Class I
- Madsen Accuscreen — Natus Medical Denmark ApS · Class IIa
Cleared under the same submission
K031352 also covers:
- Bio-logic — Natus Medical Incorporated
- Bio-logic — Natus Medical Incorporated
- Bio-logic — Natus Medical Incorporated
- Bio-logic — Natus Medical Incorporated
- Bio-logic — Natus Medical Incorporated
- Bio-logic — Natus Medical Incorporated
- Bio-logic — Natus Medical Incorporated
- Bio-logic — Natus Medical Incorporated
- Bio-logic — Natus Medical Incorporated
- Bio-logic — Natus Medical Incorporated
- Bio-logic — Natus Medical Incorporated
- Bio-logic — Natus Medical 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Incorporated
Sources (1)
- FDA UDI b539c6ff-b949-4d92-9b42-fdec2d07563d 37 fields · synced May 30, 2026