FDA UDI
In Commercial Distribution
🇺🇸 United States
ROBOT POINTS PRO-CUT
DI: 04548162336514
·
Model: D020M
·
SHOFU DENTAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- ROBOT POINTS PRO-CUT
- Primary DI
- 04548162336514
- Version / Model
- D020M
- Catalog Number
- D020M
- Company Name
- SHOFU DENTAL CORPORATION
- Labeler DUNS
- 054618202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2024-09-04
- Public Version
- 1
- Public Version Date
- 2024-09-12
- Public Version Status
- New
- Public Device Record Key
- 00a1ed0e-4c3a-4dba-82e3-bfb59b1f9918
Device Description
ROBOT POINTS PRO-CUT FG D020M 5pcs
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| DZP | INSTRUMENT, DIAMOND, DENTAL | Dental | 872.4535 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16670 | Diamond dental bur, reusable | A rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14548162336511 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 04548162336514 | GS1 | ||||
| Unit of Use | 84548162336510 | GS1 |
Customer Contacts
- Phone
- +1(760) 736-3277
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius