Identity
- Trade Name
- Etymotic FDA UDI
- Generic Name
- Tone audiometer FDA UDI
- Device Name
- Replacement Filters 6pk-orange FDA UDI
- Model / Reference
- ER38-50HT FDA UDI
- Description
- Replacement Filters 6pk-orange FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00846430004016 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Tone audiometer 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tone audiometer
Etymotic by Etymotic Research, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Benson — MAICO Diagnostics GmbH · Class II
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- VIOLA — INVENTIS SRL · Class II
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
- Etymotic Research, Inc.
Sources (1)
- FDA UDI b7097a3b-7e20-4b42-b1cb-767a753c1989 33 fields · synced May 31, 2026