FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TriPhasix™
DI: M595S4000
·
Model: S400
·
PARKELL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- TriPhasix™
- Primary DI
- M595S4000
- Version / Model
- S400
- Catalog Number
- S400
- Company Name
- PARKELL, INC.
- Labeler DUNS
- 009900424
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2019-04-01
- Public Version Status
- Update
- Public Device Record Key
- 23b45f9d-94eb-41b9-ba23-94a5e2874802
- Distribution End Date
- 2019-01-01
Device Description
1lb. TriPhasix™ Chromatic Alginate
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being 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 | M595S4043 | HIBCC | 25 | Not in Commercial Distribution | 2019-01-01 | |
| Primary | M595S4000 | HIBCC | ||||
| Package | M595S4022 | HIBCC | 10 | Not in Commercial Distribution | 2019-01-01 | |
| Package | M595S4011 | HIBCC | 5 | Not in Commercial Distribution | 2019-01-01 |
Customer Contacts
- Phone
- 6312491134
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 64 – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep container tightly closed and store in a cool, dry and well-ventilated place.