FDA UDI
In Commercial Distribution
🇺🇸 United States
DISPOSABLE FOOTSWITCH SUCTION COAGULATOR
DI: 00192896009455
·
Model: SCF12
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DISPOSABLE FOOTSWITCH SUCTION COAGULATOR
- Primary DI
- 00192896009455
- Version / Model
- SCF12
- Catalog Number
- SCF12
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-16
- Public Version
- 1
- Public Version Date
- 2018-09-17
- Public Version Status
- New
- Public Device Record Key
- c61360ea-2ae3-4744-939f-c43d8bb92b14
Device Description
DISPOSABLE FOOTSWITCH SUCTION COAGULATOR WITH CABLE
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
- 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
- ["Dry Heat Sterilization", "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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36336 | Foot-switch, electrical | An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896009455 | GS1 |
Customer Contacts
- Phone
- 800-821-7496
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033003 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 10 French Inner Diameter | ||
| Length | 3 | Meter |