FDA UDI
In Commercial Distribution
🇺🇸 United States
Durashield® CV
DI: D6870031104FG1
·
Model: 0031104FG
·
Sultan Healthcare Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Durashield® CV
- Primary DI
- D6870031104FG1
- Version / Model
- 0031104FG
- Company Name
- Sultan Healthcare Inc
- Labeler DUNS
- 056296981
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 2e9a1cc1-bcac-4b36-80a6-259d0eb47c1f
Device Description
Durashield® CV 5% Sodium Fluoride Clear Varnish Strawberry 50 Count of 0.40mL
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
- No
- 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 |
|---|---|---|---|---|
| LBH | VARNISH, CAVITY | Dental | 872.3260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35698 | Dental cavity varnish | A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D6870031104FG2 | HIBCC | Case | 12 | In Commercial Distribution | |
| Primary | D6870031104FG1 | HIBCC | ||||
| Unit of Use | D6870031104FG0 | HIBCC |
Customer Contacts
- Phone
- +1(800)989-8825
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 0.4 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight.
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius