Identity
- Trade Name
- GN Otometrics A/S FDA UDI
- Generic Name
- Auditory stimulator FDA UDI
- Model / Reference
- ELECTR LD,ENG,SNAP,24 IN PKG/7 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713315002618 FDA UDI
- 510(k) Number
- K083399 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- GMDN Term
- Auditory stimulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1900 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
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: Auditory stimulator
GN Otometrics A/S by Natus Medical Denmark ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Auditory stimulator.
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- Nucleus — Cochlear · Class III
- OAE EarTips — Natus Medical Denmark ApS · Class I
- Madsen Accuscreen — Natus Medical Denmark ApS · Class IIa
- Protektor32 Pods and Pod Kit — NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK) · Class I
- Madsen Accuscreen — Natus Medical Denmark ApS · Class IIa
- ER-1 — ETYMOTIC RESEARCH, INC. · Class II
Cleared under the same submission
K083399 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 3409ea3c-7f79-4720-a7c3-edb59027a685 33 fields · synced Jun 1, 2026