Identity
- Trade Name
- Sierra Wave FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- Acoustic Shielded Headphones FDA UDI
- Model / Reference
- 199219-200 FDA UDI
- Description
- Acoustic Shielded Headphones FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840067100523 FDA UDI
- FDA Product Code
- OLV FDA UDIGWF FDA UDIGWJ FDA UDIOLT FDA UDIIKN FDA UDIGWQ FDA UDIGWE FDA UDIJXE FDA UDI
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI882.1870 FDA UDI882.1900 FDA UDI890.1375 FDA UDI882.1890 FDA UDI882.1550 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sierra Wave by Cadwell Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Cadwell Industries, Inc.
Sources (1)
- FDA UDI 85fc1155-6570-4a3d-98cd-e0619fda7bc5 35 fields · synced Jun 9, 2026