FDA UDI
In Commercial Distribution
🇺🇸 United States
Family Wellness
DI: 00032251004278
·
Model: QKA
·
Family Dollar Stores
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Family Wellness
- Primary DI
- 00032251004278
- Version / Model
- QKA
- Company Name
- Family Dollar Stores
- Labeler DUNS
- 117310689
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-21
- Public Version
- 1
- Public Version Date
- 2020-09-29
- Public Version Status
- New
- Public Device Record Key
- a11f69c8-19d8-4a06-b101-4932ecf9a26d
Device Description
Denture Adhesive, Original
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| KOT | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | Dental | 872.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46127 | Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free | An adhesive compound composed of carboxymethylcellulose sodium and a polymer (e.g., ethylene oxide homopolymer, cationic polyacrylamide polymer, polyvinyl methylether maleic acid salt), that does not contain zinc (i.e., no zinc salts), intended to be used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. 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 | 00032251906169 | GS1 | case | 48 | In Commercial Distribution | |
| Primary | 00032251004278 | GS1 |