FDA UDI
In Commercial Distribution
🇺🇸 United States
Premium Plus
DI: D83832252
·
Model: 3225
·
Premium Plus International Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
300
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Basic Information
- Brand Name
- Premium Plus
- Primary DI
- D83832252
- Version / Model
- 3225
- Company Name
- Premium Plus International Limited
- Labeler DUNS
- 668367758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 300
- Record Status
- Published
- Publish Date
- 2020-01-08
- Public Version
- 2
- Public Version Date
- 2023-05-04
- Public Version Status
- Update
- Public Device Record Key
- f1f0c53f-2f45-42ab-bd91-1b3d9e86f4c2
Device Description
Disposable mixing pads
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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| JDZ | Mixer, Cement, For Clinical Use | Orthopedic | 888.4210 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44999 | Dental material mixing surface, chairside, single-use | A pad, tray, well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D83832252 | HIBCC | ||||
| Unit of Use | D83832250 | HIBCC |