FDA UDI
In Commercial Distribution
🇺🇸 United States
DentaPure Water Purification Bottle Cartridge
DI: 50732224005671
·
Model: DPI365B10
·
CROSSTEX INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- DentaPure Water Purification Bottle Cartridge
- Primary DI
- 50732224005671
- Version / Model
- DPI365B10
- Company Name
- CROSSTEX INTERNATIONAL, INC.
- Labeler DUNS
- 057728685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-04-08
- Public Version
- 1
- Public Version Date
- 2024-04-16
- Public Version Status
- New
- Public Device Record Key
- 8aaf33fb-e1ae-41d0-be61-042e0c88ab3f
Device Description
International Water Purification Bottle Cartridge
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EIA | Unit, operative dental | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62906 | Dental waterline disinfectant cartridge | A device in the form of a cartridge containing a disinfectant (e.g., iodine resin) intended to be integrated within a dental waterline (i.e., water fed to certain dental instruments) to maintain disinfection of the water prior to patient contact through introduction of the disinfectant. This is a disposable device not intended to be reprocessed, which has a multiple-patient use application (reusable). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00732224005676 | GS1 | ||||
| Primary | 50732224005671 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K992893 | 000 |