Identity
- Trade Name
- EarHug Pack - No Electrodes FDA UDI
- Generic Name
- Audiometric ear tip FDA UDI
- Device Name
- 25 pair of EarHugs FDA UDI
- Model / Reference
- M015404 FDA UDI
- Description
- 25 pair of EarHugs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817020020945 FDA UDI
- 510(k) Number
- K073384 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- GMDN Term
- Audiometric ear tip 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
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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Audiometric ear tip
EarHug Pack - No Electrodes by Intelligent Hearing Systems Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K073384 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
- Intelligent Hearing Systems Corp.
Sources (1)
- FDA UDI fc6004ab-a34f-4e49-b922-1183e6e928e6 34 fields · synced Jun 8, 2026