FDA UDI
In Commercial Distribution
🇺🇸 United States
MARK3
DI: D79671001
·
Model: 7100
·
CARGUS INTERNATIONAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- MARK3
- Primary DI
- D79671001
- Version / Model
- 7100
- Company Name
- CARGUS INTERNATIONAL, INC
- Labeler DUNS
- 096191093
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-04-14
- Public Version
- 4
- Public Version Date
- 2022-11-21
- Public Version Status
- Update
- Public Device Record Key
- bbb2c622-3585-4e59-90b1-b6b2a422e950
Device Description
5% Sodium Fluoride Varnish with TCP Bubble Gum Unidose 50/bx. - MARK3
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | D79671001 | HIBCC | ||||
| Unit of Use | D7967100 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 75 Degrees Fahrenheit