FDA UDI
In Commercial Distribution
🇺🇸 United States
MECTRON
DI: E322031201270010
·
Model: PS MEDICAL HANDPIECE
·
MECTRON SPA
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MECTRON
- Primary DI
- E322031201270010
- Version / Model
- PS MEDICAL HANDPIECE
- Catalog Number
- 03120127-001
- Company Name
- MECTRON SPA
- Labeler DUNS
- 436664734
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8ff1cb4b-f15d-4591-b7ba-1f53c5fc02a0
Device Description
Ultrasonic Medical 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | 878.4820 | 1 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Neurology | 882.4310 | 2 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Ear, Nose, Throat | 874.4250 | 2 |
| DZI | Drill, Bone, Powered | Dental | 872.4120 | 2 |
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | Orthopedic | 888.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47014 | Dental ultrasonic surgical system handpiece | A hand-held component of a dental ultrasonic surgical system that typically converts high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and cut bone upon contact during dental surgery. The operator regulates the energy with an electric power switch incorporated into a foot-pedal that is attached to the generator. The handpiece typically includes cables and tubing, and may serve as a conduit for irrigation to the site of intervention. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E322031201270010 | HIBCC |
Customer Contacts
- Phone
- +1 6144594922
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153743 | 000 |