FDA UDI
In Commercial Distribution
🇺🇸 United States
Magnetic Bur Block 14-Hole White
DI: 00840161308504
·
Model: 50z403A-MANI
·
ZIRC DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Magnetic Bur Block 14-Hole White
- Primary DI
- 00840161308504
- Version / Model
- 50z403A-MANI
- 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
- 4550288d-4b0b-452d-b8b1-df7573ff98b5
Device Description
"Fits FG, RA and HP bur styles Magnetic base holds burs securely and has non-slip feet for stability Drain holes are on the bottom of the bur blocks to help prevent rusting on the burs Covers are available Dimensions: 2-15/16"" x 1-1/2"" x 1/2"" 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 | 00840161308504 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 74.6 | Millimeter | |
| Width | 38.1 | Millimeter | |
| Height | 12.7 | Millimeter |