Identity
- Trade Name
- N4.5C Tips PK100 FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Probe Ear Tip, neonate, N4.5C, Yellow (pack of 100). For DPOAE and TEOAE testing. Appropriate for newborns with approx. 4.5mm (0.18") ear canal. The N4.5C probe tip is to be used with X-series probes (via Neonate Tip Holder). NB: Otodynamics probe tips are latex-free. Recommended for single use. FDA UDI
- Model / Reference
- T-N4.5C FDA UDI
- Description
- Probe Ear Tip, neonate, N4.5C, Yellow (pack of 100). For DPOAE and TEOAE testing. Appropriate for newborns with approx. 4.5mm (0.18") ear canal. The N4.5C probe tip is to be used with X-series probes (via Neonate Tip Holder). NB: Otodynamics probe tips are latex-free. Recommended for single use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060396172229 FDA UDI
- FDA Product Code
- EWO FDA UDIGWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI882.1900 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Evoked-potential audiometerOtoacoustic emission system, battery-powered
N4.5C Tips PK100 by Otodynamics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Otodynamics
Sources (1)
- FDA UDI f0da94ae-eb33-4021-8dd8-63f9796d552d 33 fields · synced May 30, 2026