Identity
- Trade Name
- Biotronix Healthcare FDA UDI
- Generic Name
- Wound irrigation kit, non-sterile FDA UDI
- Device Name
- Irrigation Tray with Bulb Syringe FDA UDI
- Model / Reference
- URHT18 FDA UDI
- Description
- Irrigation Tray with Bulb Syringe FDA UDI
Identifiers
- Catalog Number
- URHT18 FDA UDI
- Primary DI / UDI-DI
- 00850005165033 FDA UDI
- FDA Product Code
- KYZ FDA UDI
- GMDN Term
- Wound irrigation kit, non-sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6960 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
Yes
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
No
FDA UDI
Category: Wound irrigation kit, non-sterile
Biotronix Healthcare by Biotronix Healthcare Industries Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound irrigation kit, non-sterile.
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
- Biotronix Healthcare Industries Inc.
Sources (1)
- FDA UDI 6ee9d560-21ad-4da6-ab30-d6c60f70ef03 35 fields · synced May 31, 2026