FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LIPOSUCTION CANNULA
DI: B0992013800
·
Model: 201-380
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LIPOSUCTION CANNULA
- Primary DI
- B0992013800
- Version / Model
- 201-380
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-19
- Public Version
- 7
- Public Version Date
- 2019-02-21
- Public Version Status
- Update
- Public Device Record Key
- fd032605-3db5-444f-a189-7b108526205c
- Distribution End Date
- 2018-06-18
Device Description
LIPOSUCTION CANNULA SPIRAL TIP
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
- Yes
- 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", "Dry Heat Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOL | Catheter And Tip, Suction | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45414 | Liposuction system cannula, reusable | A rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B0992013800 | HIBCC |
Customer Contacts
- Phone
- 8008217496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 220x4mm Tip |