Identity
- Trade Name
- Orfit Industries FDA UDI
- Generic Name
- Tone audiometer FDA UDI
- Device Name
- DUON UH-HEAD MASK 2.4MM MICRO+ FDA UDI
- Model / Reference
- 60119-UH FDA UDI
- Description
- DUON UH-HEAD MASK 2.4MM MICRO+ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05420028772584 FDA UDI
- 510(k) Number
- K991319 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Tone audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Head/neck procedure positionerTone audiometer
Orfit Industries by Orfit Industries NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tone audiometer.
- TREMETRICS — MAICO Diagnostics GmbH · Class II
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- nanoAudio DD45 Set with Patient Response Button and Hughson-Westlake — PATH medical GmbH · Class II
- Otometrics — Natus Medical Denmark ApS · Class II
- TRIANGLE — INVENTIS SRL · Class II
- Benson — MAICO Diagnostics GmbH · Class II
- Maico — MAICO Diagnostics GmbH · Class II
- VIOLA — INVENTIS SRL · Class II
Cleared under the same submission
K991319 also covers:
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
- Orfit Industries — Orfit Industries NV
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
- Orfit Industries NV
Sources (1)
- FDA UDI 910ebb0e-d1a3-4c89-8231-a42aacd6a83d 35 fields · synced Jun 8, 2026