Identity
- Trade Name
- Natus FDA UDI
- Generic Name
- Auditory canal scanner FDA UDI
- Device Name
- 1093, DESKTOP CRADLE, ACCESSORY FDA UDI
- Model / Reference
- 8-61-20100 FDA UDI
- Description
- 1093, DESKTOP CRADLE, ACCESSORY FDA UDI
Identifiers
- Catalog Number
- 8-61-20100 FDA UDI
- Primary DI / UDI-DI
- 05713315005992 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Auditory canal scanner
Natus 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.
- GN Otometrics A/S — 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 b5e3dee0-9cf4-43af-b5bb-8c9ccc5cb546 34 fields · synced May 30, 2026