FDA UDI
In Commercial Distribution
🇺🇸 United States
SonaStar
DI: 00841626100183
·
Model: CFSM6-H190
·
MISONIX, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SonaStar
- Primary DI
- 00841626100183
- Version / Model
- CFSM6-H190
- 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
- 4
- Public Version Date
- 2018-07-24
- Public Version Status
- Update
- Public Device Record Key
- d0d89dd7-60f2-46c9-9f68-ad5ffc40a59e
Device Description
SonaStar Laparoscopic Rigid Sheath for Short Straight 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
- 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 |
|---|---|---|---|---|
| 60719 | Ultrasonic surgical system handpiece cooling sleeve | A removable attachment to an ultrasonic surgical system handpiece intended to contain the flow of coolant liquid, supplied through the handpiece, over the ultrasonic surgical system handpiece tip; the coolant is intended to prevent overheating of the tip during a surgical procedure. It is typically a funnel-shaped sleeve designed to fit over the distal end of the handpiece and cover a portion of the tip. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841626100183 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062471 | 000 |