FDA UDI
In Commercial Distribution
🇺🇸 United States
GUM Technique Sensitive Clean
DI: 00070942008105
·
Model: 524CNL
·
SUNSTAR AMERICAS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- GUM Technique Sensitive Clean
- Primary DI
- 00070942008105
- Version / Model
- 524CNL
- Catalog Number
- 524CNL
- Company Name
- SUNSTAR AMERICAS, INC.
- Labeler DUNS
- 025066358
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-19
- Public Version
- 1
- Public Version Date
- 2025-05-27
- Public Version Status
- New
- Public Device Record Key
- dca47a14-da4c-4d9c-aff9-3eedaf716110
Device Description
GUM Technique Sensitive Clean Compact Toothbrush
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 20070942008109 | GS1 | Case | 144 | In Commercial Distribution | |
| Primary | 00070942008105 | GS1 |
Customer Contacts
- Phone
- 7733554024
- [email protected]