FDA UDI
In Commercial Distribution
🇺🇸 United States
SmarTemp®
DI: 10810000526953
·
Model: S344
·
PARKELL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- SmarTemp®
- Primary DI
- 10810000526953
- Version / Model
- S344
- Catalog Number
- S344
- Company Name
- PARKELL, INC.
- Labeler DUNS
- 009900424
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2018-10-19
- Public Version
- 4
- Public Version Date
- 2023-12-21
- Public Version Status
- Update
- Public Device Record Key
- 7e825ac3-e2e3-43f4-85f6-b9c6daa714d6
Device Description
Mixing Tip with Blue Base for 50ml SmarTemp® (Pkg. of 30 pcs.)
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | Dental | 872.3770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58399 | Dental material mixing nozzle | A device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10810000526953 | GS1 | ||||
| Unit of Use | 00810000526956 | GS1 |
Customer Contacts
- Phone
- 6312491134
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991270 | 000 |