FDA UDI
In Commercial Distribution
🇺🇸 United States
Darby Dental Supply, LLC
DI: 00889813022641
·
Model: 9594802
·
DARBY DENTAL SUPPLY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Darby Dental Supply, LLC
- Primary DI
- 00889813022641
- Version / Model
- 9594802
- Catalog Number
- 9594802
- Company Name
- DARBY DENTAL SUPPLY, LLC
- Labeler DUNS
- 825137818
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2020-01-17
- Public Version
- 2
- Public Version Date
- 2020-03-23
- Public Version Status
- Update
- Public Device Record Key
- fe5ecb8e-491d-4995-a07b-c1f7e39f70da
Device Description
SINGLE USE DIAMOND 368-023C
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation 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 |
|---|---|---|---|---|
| 45525 | Diamond dental bur, single-use | 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889813022641 | GS1 | ||||
| Unit of Use | 00889813022634 | GS1 |
Customer Contacts
- Phone
- +1(516)688-6800 ext. 6431
- [email protected]