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Magnetic Bur Block 8-Hole Neon Orange
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50Z400Q
Identity
- Trade Name
- Magnetic Bur Block 8-Hole Neon Orange EUDAMEDMagnetic Bur Block - 8-Hole - Neon Orange - 1 Count EUDAMEDMagnetic Bur Block 8-Hole Orange FDA UDI
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- 8-Hole Bur Block Neon Orange EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMED
- Model / Reference
- 50Z400Q EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161302311 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840161302311 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
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 — 38.1 Millimeter FDA UDIWidth — 38.1 Millimeter FDA UDIHeight — 12.7 Millimeter FDA UDI
Magnetic Bur Block 8-Hole Neon Orange by Zirc Dental Products, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00840161302311 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161302311 | 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 76e0b300-5afb-49d9-8ce3-a930d22d5e59 61 fields · synced Jun 18, 2026
- EUDAMED cb48eb5e-9132-419c-ae40-f129f2aba7df 61 fields · synced May 17, 2026
- FDA UDI c28b8d51-c6e3-4f37-b668-b5e2d682cf30 33 fields · synced May 30, 2026