Identity
- Trade Name
- ACCLARENT AERA FDA UDI
- Generic Name
- Eustachian catheter, single-use FDA UDI
- Device Name
- ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 1 PK FDA UDI
- Model / Reference
- EU061655Z FDA UDI
- Description
- ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 1 PK FDA UDI
Identifiers
- Catalog Number
- EU061655Z FDA UDI
- Primary DI / UDI-DI
- 20705031230870 FDA UDI
- 510(k) Number
- DEN150056 FDA UDI
- FDA Product Code
- PNZ FDA UDI
- GMDN Term
- Eustachian catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4180 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Eustachian catheter, single-use
Acclarent Aera by Acclarent, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Eustachian catheter, single-use.
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- XprESS Ultra — Stryker Corp. · Class I
- XprESS LoProfile — Stryker Corp. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Acclarent, Inc.
Sources (1)
- FDA UDI 79d2130d-ac33-415a-b8e5-6ae32252bd73 37 fields · synced May 30, 2026