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Restorative Organizer - Restorative Organizer - Neon Purple - 1 Count
EUDAMEDFDA UDIClass I (EU MDR)
Ref 20Z495R
Identity
- Trade Name
- Restorative Organizer - Restorative Organizer - Neon Purple - 1 Count EUDAMEDRestorative Organizer FDA UDI
- Generic Name
- General-purpose bowl, reusable FDA UDI
- Device Name
- Non-Sterile Instrument Holders and Organizers Products EUDAMEDRestorative Organizer FDA UDI
- Model / Reference
- 20Z495R EUDAMEDFDA UDI
- Description
- Restorative Organizer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161304070 EUDAMEDFDA UDI
- Basic UDI-DI
- 08401613000233 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- V0499 CLINICAL USE CONTAINERS (NON-IVD) - OTHER EUDAMED
- GMDN Term
- General-purpose bowl, 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
Dimensions & Sizes
- Size
- Length — 117 Millimeter FDA UDIWidth — 175 Millimeter FDA UDIHeight — 16 Millimeter FDA UDI
Restorative Organizer - Restorative Organizer - Neon Purple - 1 Count by Zirc Dental Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 42e588ac-dbbd-49a3-9884-6cef132e7b0b 61 fields · synced Oct 6, 2026
- FDA UDI fbed33c1-f706-4e37-b29d-8e4c5070613f 34 fields · synced May 30, 2026