FDA UDI
In Commercial Distribution
🇺🇸 United States
Premium Plus
DI: D8383034
·
Model: 303
·
Premium Plus International Limited
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
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Basic Information
- Brand Name
- Premium Plus
- Primary DI
- D8383034
- Version / Model
- 303
- Company Name
- Premium Plus International Limited
- Labeler DUNS
- 668367758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2019-12-25
- Public Version
- 1
- Public Version Date
- 2020-01-02
- Public Version Status
- New
- Public Device Record Key
- 824ff08c-cd7a-48f6-a740-0e8a66de210c
Device Description
Dental oral evacuators
Device Characteristics
- Single Use
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38759 | Dental suction system cannula, reusable | A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D8383038 | HIBCC | CASE | 4 | In Commercial Distribution | |
| Package | D8383036 | HIBCC | BOX | 10 | In Commercial Distribution | |
| Primary | D8383034 | HIBCC | ||||
| Unit of Use | D8383030 | HIBCC |