FDA UDI
In Commercial Distribution
🇺🇸 United States
Steri-Bur Guard 12-Hole Blue
DI: 00840161301635
·
Model: 50Z406B
·
ZIRC DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Steri-Bur Guard 12-Hole Blue
- Primary DI
- 00840161301635
- Version / Model
- 50Z406B
- Company Name
- ZIRC DENTAL PRODUCTS, INC.
- Labeler DUNS
- 064783913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-27
- Public Version
- 1
- Public Version Date
- 2022-11-04
- Public Version Status
- New
- Public Device Record Key
- 787ee602-f4b5-4b7f-827d-757679752d9f
Device 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"
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16349 | Instrument transport trolley system | A combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable clinical instruments (typically endoscopes or surgical instruments) between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers; smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840161301635 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 73 | Millimeter | |
| Width | 9.5 | Millimeter | |
| Height | 34.9 | Millimeter |