Identity
- Trade Name
- DISPOSABLE FOOTSWITCH SUCTION COAGULATOR FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- DISPOSABLE FOOTSWITCH SUCTION COAGULATOR WITH CABLE FDA UDI
- Model / Reference
- SCF10 FDA UDI
- Description
- DISPOSABLE FOOTSWITCH SUCTION COAGULATOR WITH CABLE FDA UDI
Identifiers
- Catalog Number
- SCF10 FDA UDI
- Primary DI / UDI-DI
- 00192896009448 FDA UDI
- 510(k) Number
- K033003 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 3 Meter FDA UDI
Category: Foot-switch, electrical
Disposable Footswitch Suction Coagulator by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K033003 also covers:
- CONMED — Conmed Corporation
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- DISPOSABLE FOOTSWITCH SUCTION COAGULATOR — SONTEC INSTRUMENTS, INC.
- DISPOSABLE HANDSWITCH SUCTION COAGULATOR — SONTEC INSTRUMENTS, INC.
- DISPOSABLE HANDSWITCH SUCTION COAGULATOR — SONTEC INSTRUMENTS, INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 81921dfa-fc3e-4ae8-b807-3158b3a41227 37 fields · synced Jun 8, 2026