Stryker Universal Select Sterilization Tray System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Stryker Universal Select Sterilization Tray System EUDAMEDFDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Cases & Trays EUDAMED90° (Right Angle) Screwdriver Instrument Tray FDA UDI1/4 DIN Instrument/Accessory Tray FDA UDI2.0 MP Le-Fort Plates Inlay FDA UDI2.0/2.3 Mandible Screw Module FDA UDI1/4 DIN Silicone Mat FDA UDIMP Instrument Tray FDA UDIUpper-/Mid-Face Instrument Tray FDA UDITMJ Concepts Trocar Tray FDA UDI2.0/2.3 Mandible Plates Module FDA UDI2.0 TMJ Concepts Instrumentation Tray FDA UDI2.0/2.3 Mini Plates Inlay, Large FDA UDIThree Level Rack FDA UDI2.0 TMJ Concepts Screws Module – Set FDA UDI2.0 MP Standard Plates Inlay, Large FDA UDIMandible Fracture Instrument Tray FDA UDI1.7 Mid-Face Plates Module FDA UDI1/2 DIN Instrument/Accessory Tray Lid FDA UDI2.0/2.3 Mandible Recon Primary Plates Inlay FDA UDIHMMF Instrument Tray FDA UDIMandible Reconstruction Instrument Tray FDA UDIOrbital Floor Instrument Tray FDA UDI2.0/2.3 Mini Plates Inlay, Small FDA UDI1.2 Orbital Plates/Mesh Module FDA UDI2.0 MP Plates Module FDA UDI
- Model / Reference
- 29-13909 EUDAMEDFDA UDI29-13920 EUDAMEDFDA UDI29-20905 EUDAMEDFDA UDI29-23900 EUDAMEDFDA UDI29-13922 EUDAMEDFDA UDI29-13903 EUDAMEDFDA UDI29-13901 EUDAMEDFDA UDI29-13912 EUDAMEDFDA UDI29-23901 EUDAMEDFDA UDI29-13911 EUDAMEDFDA UDI29-23902 EUDAMEDFDA UDI29-13910 EUDAMEDFDA UDI29-20906 EUDAMEDFDA UDI29-20902 EUDAMEDFDA UDI29-13904 EUDAMEDFDA UDI29-17901 EUDAMEDFDA UDI29-13931 EUDAMEDFDA UDI29-23904 EUDAMEDFDA UDI29-13908 EUDAMEDFDA UDI29-13906 EUDAMEDFDA UDI29-13902 EUDAMEDFDA UDI29-23906 EUDAMEDFDA UDI29-12901 EUDAMEDFDA UDI29-20901 EUDAMEDFDA UDITRAYS EUDAMED29-13913 EUDAMED
- Description
- 90° (Right Angle) Screwdriver Instrument Tray FDA UDI1/4 DIN Instrument/Accessory Tray FDA UDI2.0 MP Le-Fort Plates Inlay FDA UDI2.0/2.3 Mandible Screw Module FDA UDI1/4 DIN Silicone Mat FDA UDIMP Instrument Tray FDA UDIUpper-/Mid-Face Instrument Tray FDA UDITMJ Concepts Trocar Tray FDA UDI2.0/2.3 Mandible Plates Module FDA UDI2.0 TMJ Concepts Instrumentation Tray FDA UDI2.0/2.3 Mini Plates Inlay, Large FDA UDIThree Level Rack FDA UDI2.0 TMJ Concepts Screws Module – Set FDA UDI2.0 MP Standard Plates Inlay, Large FDA UDIMandible Fracture Instrument Tray FDA UDI1.7 Mid-Face Plates Module FDA UDI1/2 DIN Instrument/Accessory Tray Lid FDA UDI2.0/2.3 Mandible Recon Primary Plates Inlay FDA UDIHMMF Instrument Tray FDA UDIMandible Reconstruction Instrument Tray FDA UDIOrbital Floor Instrument Tray FDA UDI2.0/2.3 Mini Plates Inlay, Small FDA UDI1.2 Orbital Plates/Mesh Module FDA UDI2.0 MP Plates Module FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857387006190 EUDAMEDFDA UDI00857387006053 EUDAMEDFDA UDI00857387006312 EUDAMEDFDA UDI00857387006329 EUDAMEDFDA UDI00857387006404 EUDAMEDFDA UDI00857387006138 EUDAMEDFDA UDI00857387006114 EUDAMEDFDA UDI00857387006985 EUDAMEDFDA UDI00857387006336 EUDAMEDFDA UDI00857387006978 EUDAMEDFDA UDI00857387006343 EUDAMEDFDA UDI00857387006046 EUDAMEDFDA UDI00857387006992 EUDAMEDFDA UDI00857387006282 EUDAMEDFDA UDI00857387006145 EUDAMEDFDA UDI00857387006237 EUDAMEDFDA UDI00857387006084 EUDAMEDFDA UDI00857387006367 EUDAMEDFDA UDI00857387006183 EUDAMEDFDA UDI00857387006169 EUDAMEDFDA UDI00857387006121 EUDAMEDFDA UDI00857387006381 EUDAMEDFDA UDI00857387006213 EUDAMEDFDA UDI00857387006275 EUDAMEDFDA UDI00857387006541 EUDAMED
- Basic UDI-DI
- 0857387006TRAYAY EUDAMED
- Direct Marketing DI
- 00857387006329 EUDAMED00857387006046 EUDAMED00857387006381 EUDAMED00857387006275 EUDAMED00857387006213 EUDAMED00857387006282 EUDAMED00857387006183 EUDAMED00857387006145 EUDAMED00857387006978 EUDAMED00857387006404 EUDAMED00857387006084 EUDAMED00857387006992 EUDAMED00857387006985 EUDAMED00857387006053 EUDAMED00857387006190 EUDAMED00857387006114 EUDAMED00857387006343 EUDAMED00857387006541 EUDAMED00857387006237 EUDAMED00857387006312 EUDAMED00857387006138 EUDAMED00857387006367 EUDAMED00857387006336 EUDAMED00857387006121 EUDAMED00857387006169 EUDAMED
- 510(k) Number
- FDA Product Code
- KCT FDA 510(k)FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 880.6850 FDA 510(k)
- Regulation Number
- 880.6850 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Stryker Universal Select Sterilization Tray System is a sterilization tray designed to organize, enclose, and protect surgical instruments and supplies during sterilization processes. It falls under the sterilization tray nomenclature category, facilitating containment and transport of items ready for sterilization in healthcare settings.
This system is intended for use in general hospital environments and is supplied as a reusable device. It is not MRI-safe and requires proper cleaning and sterilization between uses. The system is authorized under FDA 510K clearance (K173615) and MDR compliance, with model numbers 29-23905 and 29-20900 available for commercial distribution.
Frequently asked questions
What types of healthcare settings is this sterilization tray system intended for, and how does its reusable design impact its use?
The Stryker Universal Select Sterilization Tray System is designed specifically for general hospital environments. Its reusable nature means it must be thoroughly cleaned and sterilized between uses to maintain hygiene and prevent cross-contamination. This makes it suitable for high-volume settings where efficiency and repeated use are priorities, but proper sterilization protocols are essential to ensure safety and functionality.
Are there different sizes or models available for this sterilization tray system, and how might I choose the right one?
Yes, the system comes in two model numbers: 29-23905 and 29-20900. While the exact dimensions or capacity differences between these models aren’t specified, the availability of multiple models suggests they may cater to varying tray sizes or load capacities. To choose the right one, consider the volume of instruments or supplies you typically sterilize at once—larger models may accommodate heavier or bulkier loads, while smaller ones could be better for routine or less intensive use.
How should I store this sterilization tray system when not in use, and are there any special considerations for its maintenance?
Since the Stryker Universal Select Sterilization Tray System is reusable, it should be stored in a clean, dry environment to prevent dust, moisture, or damage. Before storage, ensure it is fully dry after sterilization to avoid corrosion or microbial growth. Regular cleaning and sterilization between uses are mandatory, as outlined in the manufacturer’s instructions, to uphold its performance and safety standards. Avoid storing it in areas exposed to extreme temperatures or direct sunlight.
Is this sterilization tray system compatible with any specific sterilization methods, or does it require special handling during the process?
The system is designed to organize and protect surgical instruments during sterilization but does not specify compatibility with particular sterilization methods (e.g., autoclave, ethylene oxide, or gamma irradiation). However, since it is reusable and requires cleaning and sterilization between uses, it must be processed according to standard hospital protocols for the chosen method. Always follow the manufacturer’s guidelines and facility-specific sterilization procedures to ensure proper decontamination and prevent damage to the tray.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Stryker Universal Select Sterilization Tray System - BEUDAMED, Stryker Universal Select Sterilization Tray System, AccessGUDID - DEVICE: Stryker Universal Select Sterilization Tray ..., Jobs and Careers at Stryker | Stryker Careers, Stryker Universal Select Sterilization Tray System (K173615) — FDA 510 ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173615 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragon Medical
Sources (50)
- FDA 510(k) K173615 24 fields · synced Sep 18, 2026
- FDA UDI 853f2cca-ad56-4d29-a8f9-69714244f60f 35 fields · synced May 29, 2026
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