Identity
- Trade Name
- MRIaudio Ear-Tip FDA UDI
- Generic Name
- Headphones FDA UDI
- Device Name
- Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR. FDA UDI
- Model / Reference
- 302 FDA UDI
- Description
- Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR. FDA UDI
Identifiers
- Catalog Number
- 302 FDA UDI
- Primary DI / UDI-DI
- B6693020 FDA UDI
- 510(k) Number
- K180100 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Headphones FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Headphones
MRIaudio Ear-Tip by Mriaudio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K180100 also covers:
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
- Mriaudio
Sources (1)
- FDA UDI 0a1c702e-c162-400f-bce8-2ac10fa036f8 36 fields · synced May 30, 2026