FDA UDI
In Commercial Distribution
🇺🇸 United States
Plastic Tongue Cleaners
DI: 00723896023679
·
Model: 53c2008a
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Plastic Tongue Cleaners
- Primary DI
- 00723896023679
- Version / Model
- 53c2008a
- Catalog Number
- 2039715
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-08
- Public Version
- 1
- Public Version Date
- 2023-06-16
- Public Version Status
- New
- Public Device Record Key
- eee61473-cfb7-4b96-a5d6-56d3aff2ed55
Device Description
Single piece of plastic with a handle and a head used to scrape tongue for oral hygiene. 100 pack
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
- 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 |
|---|---|---|---|---|
| LCN | Scraper, Tongue | Dental | 872.6855 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42538 | Tongue scraper, reusable | A device used to scrape the upper surface of the tongue to promote oral hygiene (e.g., to remove plaque, food debris, and bacteria, and to prevent bad breath). It is normally available [non-prescription] over-the-counter (OTC). It is typically made of copper (Cu) because of its biostatic properties (i.e., bacteria will not grow on its surface), and has a scraping ridge that is manually pulled over the surface of the tongue. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00723896023686 | GS1 | case | 12 | In Commercial Distribution | |
| Primary | 00723896023679 | GS1 |