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Foot control On/Off
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 1513nou
by Nouvag AG
Identity
- Trade Name
- Foot control On/Off FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Foot Pedal EUDAMEDFoot control On/Off for Dispenser DP 30 FDA UDI
- Model / Reference
- 1513NOU EUDAMEDFDA UDI
- Description
- Foot control On/Off for Dispenser DP 30 FDA UDI
Identifiers
- Primary DI / UDI-DI
- +ENOU1513NOU04 EUDAMEDENOU1513NOU0 FDA UDI
- Basic UDI-DI
- ++ENOU100031LG EUDAMED
- 510(k) Number
- K071588 FDA UDI
- FDA Product Code
- FRN FDA UDI
- EMDN Code
- Z12019080 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foot-switch, electrical
Foot control On/Off by Nouvag AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Foot-switch, electrical.
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- Arthrex® — Arthrex, Inc. · Class I
- CableAME — Cambridge Interventional LLC · Class IIb
- CORE — Stryker Corp. · Class II
- PowerPack — MICROLINE SURGICAL, INC. · Class II
Cleared under the same submission
K071588 also covers:
- ClosureFast — Covidien LP
- ClosureFast — Covidien LP
- Dispenser DP 30 — Nouvag AG
- Dispenser DP 30 — Nouvag AG
- Dispenser DP 30 — Nouvag AG
- Dispenser DP 30 — Nouvag AG
- Dispenser DP 30 — Nouvag AG
- Dispenser DP 30 — Nouvag AG
- Dispenser DP 30 — Nouvag AG
- Dispenser DP 30 LipoPlus — Nouvag AG
- Dispenser DP 30 LipoPlus — Nouvag AG
- Dispenser DP 30 LipoPlus — Nouvag AG
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nouvag AG
Sources (2)
- FDA UDI bc3cd8d9-344d-4834-bfb9-d52d65f8dffb 35 fields · synced Jun 18, 2026
- EUDAMED d4627979-0997-4a0b-b9e7-9581776aa1b2 61 fields · synced Jun 18, 2026