Identity
- Trade Name
- PST Corp. FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Silicone Bar 2 Slot, Open 13mm Slot and Closed 7mm Slot EUDAMEDFDA UDI
- Model / Reference
- 6520S EUDAMEDFDA UDI
- Description
- Silicone Bar 2 Slot, Open 13mm Slot and Closed 7mm Slot FDA UDI
Identifiers
- Catalog Number
- 6520S FDA UDI
- Primary DI / UDI-DI
- 00810051831504 EUDAMEDFDA UDI
- Basic UDI-DI
- 8100518314816502S54 EUDAMED
- Direct Marketing DI
- 00810051831504 EUDAMED
- FDA Product Code
- FSM 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 EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Instrument tray, reusable
PST Corp. by Tray Plastic Sterilizing Corporation Inc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tray Plastic Sterilizing Corporation Inc
Sources (2)
- FDA UDI b2203914-952c-4f05-a3bc-a6c0e09527ca 35 fields · synced Jul 18, 2026
- EUDAMED ed08e113-29f8-49e9-86b1-e8613259bf9b 61 fields · synced Jul 18, 2026