FDA UDI
In Commercial Distribution
🇺🇸 United States
Darby Dental Supply, LLC
DI: D82795004100
·
Model: 9500410
·
DARBY DENTAL SUPPLY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Darby Dental Supply, LLC
- Primary DI
- D82795004100
- Version / Model
- 9500410
- Catalog Number
- 9500410
- Company Name
- DARBY DENTAL SUPPLY, LLC
- Labeler DUNS
- 825137818
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-17
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 7db82075-6a76-4ba9-a0e4-ded81ef22328
Device Description
ALGINATE DUSTLESS FAST SET 1LB
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELW | MATERIAL, IMPRESSION | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35863 | Alginate dental impression material | A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D82795004100 | HIBCC |
Customer Contacts
- Phone
- +1(516)688-6800 ext. 6431
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 12 cans, 454 g each | ||
| Weight | 454 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 29 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry.