Identity
- Trade Name
- 22-Hole Bur Guard Midnight Blue EUDAMEDSteri-Bur Guard - Bur Holder - 22-Hole - Midnight - 1 Count EUDAMEDSteri-Bur Guard 22-Hole Midnight Blue FDA UDI
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- 22-Hole Bur Guard Midnight 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 one bur guard which enables long and short burs to be used in the same bur guard Dimensions: 4-7/8"" x 7/16"" x 1-1/2"" Autoclavable up to 136°C/275°F Washer-disinfect" FDA UDI
- Model / Reference
- 50Z410T 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 one bur guard which enables long and short burs to be used in the same bur guard Dimensions: 4-7/8"" x 7/16"" x 1-1/2"" Autoclavable up to 136°C/275°F Washer-disinfect" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161301864 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840161301864 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 — 123.8 Millimeter FDA UDIWidth — 11.1 Millimeter FDA UDIHeight — 38.1 Millimeter FDA UDI
Category: Instrument tray, reusable
22-Hole Bur Guard Midnight 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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Also classified as Instrument tray, reusable.
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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-00840161301864 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161301864 | 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 b164268d-a71b-4fc4-88d2-a4718b7013fe 61 fields · synced Jul 13, 2026
- EUDAMED 1eef11a0-feb0-4bb9-b797-6bb1e7645d52 61 fields · synced May 17, 2026
- FDA UDI 83897e30-c395-423d-825b-c0ae9f9c0677 34 fields · synced May 29, 2026