Identity
- Trade Name
- Footswitch SupraFuser FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Footswitch for Ultrasonic Generator FDA UDI
- Model / Reference
- Footswitch SupraFuser FDA UDI
- Description
- Footswitch for Ultrasonic Generator FDA UDI
Identifiers
- Catalog Number
- FS04-002 FDA UDI
- Primary DI / UDI-DI
- 07649990202358 FDA UDI
- FDA Product Code
- NKB FDA UDIHWC FDA UDIGAT FDA UDIMAI FDA UDIHTY FDA UDI
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3040 FDA UDI878.5000 FDA UDI888.3030 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foot-switch, electrical
Footswitch SupraFuser by Surgical Fusion Technologies GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K171228 also covers:
K240288 also covers:
- Drill S-PI-A1.6 — Surgical Fusion Technologies GmbH
- Drill S-PI-A2.3 — Surgical Fusion Technologies GmbH
- Drill S-PI-A3.0 — Surgical Fusion Technologies GmbH
- Guide S-PI / W5.0 — Surgical Fusion Technologies GmbH
- Handpiece Front Cover — Surgical Fusion Technologies GmbH
- Handpiece SupraFuser — Surgical Fusion Technologies GmbH
- SF Push-in Anchor 1.6 — Surgical Fusion Technologies GmbH
- SF Push-in Anchor 2.3 — Surgical Fusion Technologies GmbH
- SF Push-in Anchor 3.0 — Surgical Fusion Technologies GmbH
- Sonotrode S-PI — Surgical Fusion Technologies GmbH
- Stopper S-PI-A1.6 — Surgical Fusion Technologies GmbH
- Stopper S-PI-A2.3 — Surgical Fusion Technologies GmbH
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
- Surgical Fusion Technologies GmbH
Sources (1)
- FDA UDI 25f208ef-ef37-4043-a1d1-a2bf622ad3c3 37 fields · synced May 30, 2026