Identity
- Trade Name
- GN Otometrics A/S FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Model / Reference
- 1021, EAR TIP KIT, 6MM 50PCS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713315005374 FDA UDI
- 510(k) Number
- K033645 FDA UDI
- FDA Product Code
- ETY FDA UDI
- GMDN Term
- Impedance audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1090 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Impedance audiometer
The GN Otometrics A/S device is a high-end, accurate, and user-friendly auditory impedance audiometer designed for evaluating the functional condition of the middle ear. It provides detailed information on tympanic membrane mobility, acoustic reflex threshold, and healing processes, making it an essential tool for various medical professionals.
Similar devices
Also classified as Impedance audiometer.
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- Silicone Ear Tips — Natus Medical Denmark ApS · Class I
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Cleared under the same submission
K033645 also covers:
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
Sources (1)
- FDA UDI 86fd2aac-2da7-4a0c-8579-3936551d0edf 33 fields · synced Jul 22, 2026