FDA UDI
In Commercial Distribution
🇺🇸 United States
Darby Dental Supply, LLC
DI: 00889813051283
·
Model: 5251871
·
DARBY DENTAL SUPPLY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Darby Dental Supply, LLC
- Primary DI
- 00889813051283
- Version / Model
- 5251871
- Catalog Number
- 5251871
- Company Name
- DARBY DENTAL SUPPLY, LLC
- Labeler DUNS
- 825137818
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2021-02-19
- Public Version
- 1
- Public Version Date
- 2021-03-01
- Public Version Status
- New
- Public Device Record Key
- 4cea5c70-e2fe-4a1f-a7fe-abfefdc836c9
Device Description
INTRAORAL CLEAR RIBBON TIPS
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZM | NEEDLE, DENTAL | Dental | 872.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38790 | Dental impression material mixer | A mains electricity (AC-powered) device designed for mixing to produce a dental impression material chairside immediately before application to the oral cavity of a patient during a dental procedure. It is typically used to blend a salt of alginic acid (i.e., alginate) with water (and appropriate additives if necessary) to produce a dental impression material of rapid irreversible setting. The device typically consists of an electrical mixer with a well, a container (e.g., cup) used to mix the alginate with water before placing in the mixer well, and external controls to operate the mixer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00889813050965 | GS1 | ||||
| Primary | 00889813051283 | GS1 |
Customer Contacts
- Phone
- +1(516)688-6800 ext. 6431
- [email protected]