Magnetic Bur Block 8-Hole Neon Yellow
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Magnetic Bur Block 8-Hole Neon Yellow EUDAMEDFDA UDIMagnetic Bur Block - 8-Hole - Neon Yellow - 1 Count EUDAMED
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- 8-Hole Bur Block Neon Yellow EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMED
- Model / Reference
- 50Z400O EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161302298 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840161302298 EUDAMED0840161300083F EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument transport trolley system 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
Single Use
No
Implantable
No
Reusable
No
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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 38.1 Millimeter FDA UDIWidth — 38.1 Millimeter FDA UDIHeight — 12.7 Millimeter FDA UDI
Category: Instrument tray, reusable
Magnetic Bur Block 8-Hole Neon Yellow by Zirc Dental Products, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00840161302298 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161302298 | 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 (3)
- EUDAMED 9e79aa08-fa65-4137-958e-314f87382917 61 fields · synced Sep 17, 2026
- EUDAMED 260b1ee6-8ef3-4333-99ad-94525280fd43 61 fields · synced May 18, 2026
- FDA UDI b8b7d2df-339a-4fd2-9f32-ffce8e8e3b38 33 fields · synced May 30, 2026