Identity
- Trade Name
- Steri-Bur Guard 12-Hole Blue FDA UDI
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- "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-BEN FDA 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
- 00840161308542 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Instrument transport trolley system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 transport trolley system
Steri-Bur Guard 12-Hole Blue by Zirc Dental Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zirc Dental Products, Inc.
Sources (1)
- FDA UDI 20d8aa2e-58cf-498a-8237-3bc62ca6eb88 34 fields · synced Jun 1, 2026