Identity
- Trade Name
- Ear Tip IT-03 Pack/100 pcs. FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Insert Earphone Tips FDA UDI
- Model / Reference
- 100900-100 FDA UDI
- Description
- Insert Earphone Tips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223143267 FDA UDI
- 510(k) Number
- K133012 FDA UDI
- FDA Product Code
- EWO FDA UDIGWJ FDA UDIETT FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI882.1900 FDA UDI874.1100 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
Yes
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: Evoked-potential audiometer
Ear Tip IT-03 Pack/100 pcs. by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evoked-potential audiometer.
- ECochG Adapters — Vivosonic Inc · Class II
- TE Tip Sample Box — Otodynamics · Class II
- Tip Sample Box (Neonate) — Otodynamics · Class II
- Otoport LCD service kit — Otodynamics · Class II
- TEOAE probe tips — Otodynamics · Class II
- ABR Case service kit - Top — Otodynamics · Class II
- Otoport ABR Binaural Upgrade Kit (TE) — Otodynamics · Class II
- ABR Test Cavity — Otodynamics · Class II
Cleared under the same submission
K133012 also covers:
- AuDX Device with touchscreen — PATH medical GmbH
- AuDX PRO FLEX Device with touchscreen — PATH medical GmbH
- Bone Conductor B71W — PATH medical GmbH
- Bone Conductor B81 — PATH medical GmbH
- Bone Conductor B81 — PATH medical GmbH
- Ear Coupler Cable — PATH medical GmbH
- Ear Coupler Cable — PATH medical GmbH
- Ear Coupler Set — PATH medical GmbH
- Ear Tip IT-02 Pack/100 pcs. — PATH medical GmbH
- Headphone DD-45 contra — PATH medical GmbH
- Headphone DD-65 — PATH medical GmbH
- Headphone HDA 280 — PATH medical GmbH
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
- PATH medical GmbH
Sources (1)
- FDA UDI 9a4531d4-b280-44b6-8fdd-84045be7ddd0 34 fields · synced Jun 6, 2026