FDA UDI
In Commercial Distribution
🇺🇸 United States
TriPhasix™
DI: 00810000526154
·
Model: S400
·
PARKELL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- TriPhasix™
- Primary DI
- 00810000526154
- Version / Model
- S400
- Catalog Number
- S400
- Company Name
- PARKELL, INC.
- Labeler DUNS
- 009900424
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-23
- Public Version
- 2
- Public Version Date
- 2023-01-09
- Public Version Status
- Update
- Public Device Record Key
- 7fb81065-1553-439c-8b50-34f5e820e63e
Device Description
1lb. TriPhasix™ Chromatic Alginate
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| ELW | Material, Impression | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35863 | Alginate dental impression material | A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30810000526155 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 00810000526154 | GS1 | ||||
| Package | 20810000526158 | GS1 | Box | 10 | In Commercial Distribution | |
| Package | 10810000526151 | GS1 | Box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 6312491134
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep container tightly closed and store in a cool, dry and well-ventilated place.
- Type
- Storage Environment Temperature
- Temperature Range
- 3 – 25 Degrees Celsius