Identity
- Trade Name
- EZX FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- N/A EZX Sterilization Tray FDA UDI
- Model / Reference
- XZT1000 FDA UDI
- Description
- N/A EZX Sterilization Tray FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800038053182 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Ezx by Imedicom Co., Ltd. — 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 |
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Manufacturer
- Manufacturer
- Imedicom Co., Ltd.
Sources (1)
- FDA UDI 83c8b2c2-2ca8-44d9-aad4-76671989e3aa 34 fields · synced May 30, 2026