FDA UDI
In Commercial Distribution
🇺🇸 United States
DuraMax
DI: 00628504370834
·
Model: HP3056
·
Beyes Dental Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DuraMax
- Primary DI
- 00628504370834
- Version / Model
- HP3056
- Company Name
- Beyes Dental Canada Inc
- Labeler DUNS
- 244261462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-27
- Public Version
- 1
- Public Version Date
- 2020-08-04
- Public Version Status
- New
- Public Device Record Key
- 8d92acde-2d11-4de4-9202-b9fbcdd8bbee
Device Description
M800-M/PD/NS PLUS Beyes PD Backend, Single Stream, Safeguard Air Technology, Direct-LED
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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 40958 | Dental power tool system handpiece, pneumatic | A hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally driven by compressed air, and which typically has a built-in water spray for cooling the rotating device; the endpiece(s) are not included. The handpiece is typically connected through the dental delivery system or a freestanding independent system. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628504370834 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112623 | 000 |