FDA UDI
In Commercial Distribution
🇺🇸 United States
Rexall
DI: 00850039396014
·
Model: 25959701
·
DOLGENCORP, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Rexall
- Primary DI
- 00850039396014
- Version / Model
- 25959701
- Company Name
- DOLGENCORP, LLC
- Labeler DUNS
- 068331990
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-31
- Public Version
- 1
- Public Version Date
- 2023-09-08
- Public Version Status
- New
- Public Device Record Key
- 853bbc44-3084-41a1-8c40-4fd8f5e00712
Device Description
Rexall DGH Denture Adhesive Cream - Super Hold
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 |
|---|---|---|---|---|
| KOO | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | Dental | 872.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46132 | Polyvinyl methylether maleic acid calcium-sodium double salt denture adhesive | An adhesive compound composed of polyvinyl methylether maleic acid calcium-sodium double salt 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 |
|---|---|---|---|---|---|---|
| Primary | 00850039396014 | GS1 |