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OtoClear® Ear Irrigation System (220V)
FDA UDIClass I (US FDA UDI)
by Bionix, LLC
Identity
- Trade Name
- OtoClear® Ear Irrigation System (220V) FDA UDI
- Generic Name
- Ear canal lavage system FDA UDI
- Device Name
- OtoClear® Ear Irrigation System (220V)- 5 Tips FDA UDI
- Model / Reference
- OC-07282 FDA UDI
- Description
- OtoClear® Ear Irrigation System (220V)- 5 Tips FDA UDI
Identifiers
- Catalog Number
- 7282 FDA UDI
- Primary DI / UDI-DI
- 00714646000972 FDA UDI
- FDA Product Code
- LRD FDA UDI
- GMDN Term
- Ear canal lavage system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.5220 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
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: Ear canal lavage system
OtoClear® Ear Irrigation System (220V) by Bionix, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ear canal lavage system.
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- Baria — Shenzhen Baria Technology CO., Ltd · Class I
- Baria — Shenzhen Baria Technology CO., Ltd · 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
- Bionix, LLC
Sources (1)
- FDA UDI a9ae5858-87bf-4d74-83f4-17c2f01d39b3 35 fields · synced Jun 8, 2026