Identity
- Trade Name
- GN Otometrics A/S FDA UDI
- Generic Name
- Auditory canal scanner FDA UDI
- Model / Reference
- Specula 3 mm Cerumen FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713315000072 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Auditory canal scanner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4770 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Auditory canal scanner
GN Otometrics A/S by Natus Medical Denmark ApS — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Auditory canal scanner.
- Natus — Natus Medical Denmark ApS · Class I
- GN Otometrics A/S — Natus Medical Denmark ApS · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
Sources (1)
- FDA UDI 1ccc10fe-31b3-43f2-b39b-361062f24694 32 fields · synced May 30, 2026