Identity
- Trade Name
- ONE TRAY® Processing Kit FDA UDI
- Generic Name
- Sterilization packaging, reusable FDA UDI
- Model / Reference
- OTK-BOX50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859522006010 FDA UDI
- 510(k) Number
- K052567 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Sterilization packaging, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Sterilization packaging, reusable
ONE TRAY® Processing Kit by Innovative Sterilization Techn — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K052567 also covers:
- ONE TRAY® Sealed Sterilization Container — INNOVATIVE STERILIZATION TECHN
- ONE TRAY® Sealed Sterilization Container — INNOVATIVE STERILIZATION TECHN
- ONE TRAY® Sealed Sterilization Container — INNOVATIVE STERILIZATION TECHN
- ONE TRAY® Sealed Sterilization Container — INNOVATIVE STERILIZATION TECHN
- ONE TRAY® Sealed Sterilization Container — INNOVATIVE STERILIZATION TECHN
- ONE TRAY® Sealed Sterilization Container — INNOVATIVE STERILIZATION TECHN
- ONE TRAY® Sealed Sterilization Container — INNOVATIVE STERILIZATION TECHN
- ONE TRAY® Sealed Sterilization Container — INNOVATIVE STERILIZATION TECHN
- ONE TRAY® Sealed Sterilization Container — INNOVATIVE STERILIZATION TECHN
- ONE TRAY® Sealed Sterilization Container — INNOVATIVE STERILIZATION TECHN
- ONE TRAY® Sealed Sterilization Container — INNOVATIVE STERILIZATION TECHN
- ONE TRAY® Sealed Sterilization Container — INNOVATIVE STERILIZATION TECHN
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
- Innovative Sterilization Techn
Sources (1)
- FDA UDI de3bef53-b4f9-4eba-a52a-f1f1298a612b 33 fields · synced May 30, 2026