FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BUSCH®, BNA®
DI: D8120148851
·
Model: 303RS 050 STEEL ST RA
·
BUSCH & CO. GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
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Basic Information
- Brand Name
- BUSCH®, BNA®
- Primary DI
- D8120148851
- Version / Model
- 303RS 050 STEEL ST RA
- Catalog Number
- 014885
- Company Name
- BUSCH & CO. GmbH & Co. KG
- Labeler DUNS
- 315658617
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2022-09-01
- Public Version
- 2
- Public Version Date
- 2023-07-07
- Public Version Status
- Update
- Public Device Record Key
- ff72ee8a-a1b0-4e1e-8922-830b6938552c
- Distribution End Date
- 2023-07-07
Device Description
Steel - Mandrels
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJL | Bur, Dental | Dental | 872.3240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35170 | Dental mandrel | A slender, round, metal shaft designed to be used chairside to hold (locked into place) a rotating dental device, e.g., a grinding wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D8120148850 | HIBCC | ||||
| Primary | D8120148851 | HIBCC |