FDA UDI
In Commercial Distribution
🇺🇸 United States
SonaStar
DI: 00841626100022
·
Model: CFSX6-H321
·
MISONIX, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SonaStar
- Primary DI
- 00841626100022
- Version / Model
- CFSX6-H321
- Company Name
- MISONIX, INC.
- Labeler DUNS
- 065963449
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 777050d8-9651-4c98-ae42-31bdad8bf0c8
Device Description
SonaStar Short Straight 23 kHz Universal 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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44750 | Soft-tissue ultrasonic surgical system handpiece, reusable | A hand-held component of an ultrasonic surgical system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation for a tip placed at its end to mechanically fragment soft-tissue cells upon contact for cutting and/or coagulating tissue during surgery. The handpiece may also serve as a conduit for irrigation and aspiration during surgery. It is typically in the form of a pen/pencil or elongated probe with permanently attached cables. This is a non-dedicated device intended to be used in multiple clinical specialties. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841626100022 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062471 | 000 |