FDA UDI
In Commercial Distribution
🇺🇸 United States
Rexall
DI: 00850010842882
·
Model: 25454901
·
DOLGENCORP, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Rexall
- Primary DI
- 00850010842882
- Version / Model
- 25454901
- Company Name
- DOLGENCORP, LLC
- Labeler DUNS
- 068331990
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2020-06-25
- Public Version
- 2
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- eb986694-2357-4e64-901c-8360284f1a3c
- Distribution End Date
- 2030-06-25
Device Description
Rexall Enamel Protect Kids Extra Soft 2PK
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EFW | Toothbrush, Manual | Dental | 872.6855 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31817 | Basic manual toothbrush | An instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850010842882 | GS1 | ||||
| Unit of Use | 50850010842887 | GS1 |