Identity
- Trade Name
- Integrated Power Console FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- FOOT SWITCH 1898430 ROHS FDA UDI
- Model / Reference
- 1898430 FDA UDI
- Description
- FOOT SWITCH 1898430 ROHS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169931398 FDA UDI
- 510(k) Number
- K081277 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4250 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Foot-switch, electrical
Integrated Power Console by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K081277 also covers:
- IPC Visao® — MEDTRONIC XOMED, INC.
- IPC™ Visao® — MEDTRONIC XOMED, INC.
- Indigo — MEDTRONIC XOMED, INC.
- Indigo — MEDTRONIC XOMED, INC.
- Indigo™ — MEDTRONIC XOMED, INC.
- Indigo™ — MEDTRONIC XOMED, INC.
- Indigo™ — MEDTRONIC XOMED, INC.
- Indigo™ — MEDTRONIC XOMED, INC.
- Integrated Power Console — MEDTRONIC XOMED, INC.
- Integrated Power Console — MEDTRONIC XOMED, INC.
- Midas Rex Clearview — MEDTRONIC XOMED, INC.
- Midas Rex Clearview — MEDTRONIC XOMED, 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
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI df9b8155-19af-4935-a1d5-d19d44a9b3a1 36 fields · synced Jun 1, 2026