← Back to catalogue
OtoClear SprayWash System, Single Use
FDA UDIEUDAMEDClass I (US FDA UDI)
by Bionix, LLC
Identity
- Trade Name
- OtoClear SprayWash System, Single Use FDA UDI
- Generic Name
- Ear canal irrigation kit, reusable FDA UDI
- Device Name
- OtoClear Spray Wash System, Single Use FDA UDI
- Model / Reference
- 7291 FDA UDI
- Description
- OtoClear Spray Wash System, Single Use FDA UDI
Identifiers
- Catalog Number
- 7291 FDA UDI
- Primary DI / UDI-DI
- 00714646000729 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
- 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
Category: Ear canal irrigation kit, reusable
OtoClear SprayWash System, Single Use by Bionix, LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ear canal irrigation kit, reusable.
- EarClear Rx — NUANCE MEDICAL, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Cleanse Right — BLUE ECHO CARE · Class I
- Stradis Medical, LLC — STRADIS MEDICAL, LLC
- Cleanse Right — BLUE ECHO CARE · Class I
- Doctor Easy Medical Products — DOCTOR EASY MEDICAL PRODUCTS CORPORATION · Class I
- caring mill — BLUE ECHO CARE · Class I
- Doctor Easy Medical Products — DOCTOR EASY MEDICAL PRODUCTS CORPORATION · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| 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 (2)
- FDA UDI d6a1f5e3-8b4d-456a-9ff8-51a943dcfb6c 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026