FDA UDI
In Commercial Distribution
🇺🇸 United States
DawnMist
DI: 00665973012902
·
Model: DA2
·
Dukal LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- DawnMist
- Primary DI
- 00665973012902
- Version / Model
- DA2
- Catalog Number
- DA2
- Company Name
- Dukal LLC
- Labeler DUNS
- 791014871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-06
- Public Version
- 1
- Public Version Date
- 2022-12-14
- Public Version Status
- New
- Public Device Record Key
- 0ee9c035-af2d-42dc-90cf-adca35d71f3f
Device Description
Denture Adhesive 2 oz
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| KOO | ADHESIVE, DENTURE, POLYVINYL METHYLETHER MALEIC ACID CALCIUM-SODIUM DOUBLE SALT | 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 | 10665973012909 | GS1 | Box | 36 | In Commercial Distribution | |
| Primary | 00665973012902 | GS1 | ||||
| Package | 20665973012906 | GS1 | Case | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(631)656-3800 ext. 172
- [email protected]