Identity
- Trade Name
- SteriZIgn Sterilization Tray FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- standard tray 10x20x3 inches FDA UDI
- Model / Reference
- STER10x20x3 FDA UDI
- Description
- standard tray 10x20x3 inches FDA UDI
Identifiers
- Primary DI / UDI-DI
- G476STER10X20X3 FDA UDI
- 510(k) Number
- K171520 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
SteriZIgn Sterilization Tray by Sterizign Precision Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Sterizign Precision Technologies, LLC
Sources (1)
- FDA UDI c07c4898-331c-4aae-b7e2-fbef3f06c705 36 fields · synced May 30, 2026