Identity
- Trade Name
- Tinearity FDA UDI
- Generic Name
- Bone-conduction tinnitus masker FDA UDI
- Model / Reference
- G1 FDA UDI
Identifiers
- Catalog Number
- 6103 FDA UDI
- Primary DI / UDI-DI
- 07350136210099 FDA UDI
- 510(k) Number
- K223694 FDA UDI
- FDA Product Code
- KLW FDA UDI
- GMDN Term
- Bone-conduction tinnitus masker FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3400 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone-conduction tinnitus masker
Tinearity by Duearity AB — 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
- Duearity AB
Sources (1)
- FDA UDI 87f79f23-e81c-4168-9a68-bd8462d84c1a 34 fields · synced May 30, 2026