← Back to catalogue
OtoClear SprayWash System, Single Use Sample
FDA UDIClass I (US FDA UDI)
by Bionix, LLC
Identity
- Trade Name
- OtoClear SprayWash System, Single Use Sample FDA UDI
- Generic Name
- Ear canal irrigation kit, reusable FDA UDI
- Device Name
- OtoClear SprayWash System, Single Use Sample FDA UDI
- Model / Reference
- 27291 FDA UDI
- Description
- OtoClear SprayWash System, Single Use Sample FDA UDI
Identifiers
- Catalog Number
- 27291 FDA UDI
- Primary DI / UDI-DI
- 00714646000736 FDA UDI
- FDA Product Code
- LRD FDA UDI
- GMDN Term
- Ear canal irrigation kit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.5220 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
OtoClear SprayWash System, Single Use Sample by Bionix, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bionix, LLC
Sources (1)
- FDA UDI ae4b3d0d-1f06-4a9b-a10b-26c511a128c0 36 fields · synced Jun 8, 2026