FDA UDI
In Commercial Distribution
🇺🇸 United States
Premium Plus
DI: D838100242
·
Model: 1002-4
·
Premium Plus International Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Premium Plus
- Primary DI
- D838100242
- Version / Model
- 1002-4
- Company Name
- Premium Plus International Limited
- Labeler DUNS
- 668367758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-01
- Public Version
- 1
- Public Version Date
- 2019-02-01
- Public Version Status
- New
- Public Device Record Key
- 0fe7cb66-7ba4-451a-8e22-7149b0b23021
Device Description
Dental prophy air motor, pneumatic, dental handpiece
Device Characteristics
- Single Use
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43698 | Dental power tool system, pneumatic | An assembly of devices designed to bore and excavate bones, teeth, and tough tissues during a dental surgical procedure. It typically consists of a motorized drill handpiece and/or motor, a control unit, and a variety of attachments used to hold the drilling/excavating instruments (e.g., drill bits, burs, polishing disks). This system is pneumatically-powered (gas-powered), normally by compressed air via a connecting hose to the handpiece/motor. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D838100248 | HIBCC | case | 5 | In Commercial Distribution | |
| Package | D838100246 | HIBCC | carton | 10 | In Commercial Distribution | |
| Primary | D838100242 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170261 | 000 |