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Tray Cover - Fits Zirc B-Lok Tray (B-Size) - 1 Count
EUDAMEDFDA UDIClass I (EU MDR)
Ref 20Z441
Identity
- Trade Name
- Tray Cover - Fits Zirc B-Lok Tray (B-Size) - 1 Count EUDAMEDTray Cover FDA UDI
- Generic Name
- Instrument tray cover, reusable FDA UDI
- Device Name
- Non-Sterile Instrument Holders and Organizers Products EUDAMEDTray Cover - Fits Zirc B-Lok Tray (B-Size) - 1 Count FDA UDI
- Model / Reference
- 20Z441 EUDAMEDFDA UDI
- Description
- Tray Cover - Fits Zirc B-Lok Tray (B-Size) - 1 Count FDA UDI
Identifiers
- Catalog Number
- 20Z441 FDA UDI
- Primary DI / UDI-DI
- 00840161309570 EUDAMEDFDA UDI
- Basic UDI-DI
- 08401613000233 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- V0480 CLINICAL USE CONTAINERS (NON-IVD) - ACCESSORIES EUDAMED
- GMDN Term
- Instrument tray cover, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical instrument/implant rack
Tray Cover - Fits Zirc B-Lok Tray (B-Size) - 1 Count by Zirc Dental Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 08401613000233 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zirc Dental Products Inc.
- EUDAMED SRN
- US-MF-000021065
- Authorised Representative
- Medicom GmbH DE-AR-000005612
Sources (2)
- EUDAMED bb4d4d22-3feb-48db-af81-586b6bc0468e 61 fields · synced Jul 23, 2026
- FDA UDI 8c90e1c8-51ec-40a9-a025-2edcde65cd85 34 fields · synced May 30, 2026