FDA UDI
In Commercial Distribution
🇺🇸 United States
DX-Mixer
DI: 08800017901923
·
Model: 130
·
DXM CO., LTD
Product Codes
1
GMDN Terms
1
Identifiers
7
Pkg Device Count
1
Basic Information
- Brand Name
- DX-Mixer
- Primary DI
- 08800017901923
- Version / Model
- 130
- Company Name
- DXM CO., LTD
- Labeler DUNS
- 688797315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-04
- Public Version
- 1
- Public Version Date
- 2024-06-12
- Public Version Status
- New
- Public Device Record Key
- d317544a-e000-450e-8797-67c134d2cace
Device Description
The dental impression material mixed with a base and a catalyst is used in a dental clinic rapidly to obtain the dental impression. The dental impression material is normally housed in cartridge assembly. The impression cartridge assembly consists of a base impression cartridge and a catalyst impression cartridge parts each.
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
- 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 |
|---|---|---|---|---|
| EID | Syringe, Restorative And Impression Material | Dental | 872.4565 | 1 |
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 |
|---|---|---|---|---|---|---|
| Package | 08800017900292 | GS1 | Zip bag | 48 | In Commercial Distribution | |
| Primary | 08800017901923 | GS1 | ||||
| Package | 08800017900377 | GS1 | Zip bag | 12 | In Commercial Distribution | |
| Package | 08800017900384 | GS1 | Zip bag | 100 | In Commercial Distribution | |
| Package | 08800017900391 | GS1 | Zip bag | 500 | In Commercial Distribution | |
| Package | 08800017900407 | GS1 | Bulk | 5000 | In Commercial Distribution | |
| Package | 08800017901916 | GS1 | Zip bag | 50 | In Commercial Distribution |