Identity
- Trade Name
- 12-Hole Bur Guard Blue EUDAMEDSteri-Bur Guard - Bur Holder - 12-Hole - Blue - 1 Count EUDAMEDSteri-Bur Guard 12-Hole Blue FDA UDI
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- 12-Hole Bur Guard Blue EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMED"Protects bur from being damaged during ultrasonic cleaning and sterilization Fits latch, friction grip and HP burs Adjustable height for multiple length burs Drain holes on the bottom of the bur guard help prevent rusting on the burs One short bur adapter comes with bur guard which enables long and short burs to be used in the same bur guard Dimensions: 2-7/8"" x 3/8"" x 1-3/8"" Autoclavable up to 136°C/275°F Washer-disinfect" FDA UDI
- Model / Reference
- 50Z406B EUDAMEDFDA UDI
- Description
- "Protects bur from being damaged during ultrasonic cleaning and sterilization Fits latch, friction grip and HP burs Adjustable height for multiple length burs Drain holes on the bottom of the bur guard help prevent rusting on the burs One short bur adapter comes with bur guard which enables long and short burs to be used in the same bur guard Dimensions: 2-7/8"" x 3/8"" x 1-3/8"" Autoclavable up to 136°C/275°F Washer-disinfect" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161301635 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840161301635 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 — 73 Millimeter FDA UDIWidth — 9.5 Millimeter FDA UDIHeight — 34.9 Millimeter FDA UDI
Category: Instrument tray, reusable
12-Hole Bur Guard Blue 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
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-00840161301635 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161301635 | 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 b6007acd-5ffa-41e3-9a25-972ba3f3d990 61 fields · synced Jul 24, 2026
- EUDAMED e223abb8-c2c5-4d4b-b2e3-e621bba99860 61 fields · synced May 19, 2026
- FDA UDI 787ee602-f4b5-4b7f-827d-757679752d9f 34 fields · synced May 30, 2026