Identity
- Trade Name
- PST Corp. FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- 6124A DEEP BASE, LID & BASE MAT EUDAMEDDeep Base Lid & Base Mat FDA UDI
- Model / Reference
- 6124A EUDAMEDFDA UDI
- Description
- Deep Base Lid & Base Mat FDA UDI
Identifiers
- Catalog Number
- 6124A FDA UDI
- Primary DI / UDI-DI
- 00810051830613 EUDAMEDFDA UDI
- Basic UDI-DI
- 081005183S010401AU 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
6124a Deep Base, Lid & Base Mat by Plastic Sterilizing Tray Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081005183S010401AU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Plastic Sterilizing Tray Corporation
- EUDAMED SRN
- US-MF-000035856
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED e1c4c035-ed36-4a24-9d7a-fe7bf03f2a26 61 fields · synced Jun 18, 2026
- FDA UDI 6fcd16cc-b179-4c75-8d94-a071437b7fd7 35 fields · synced May 30, 2026