Identity
- Trade Name
- Visao® FDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- COOLING SET 3318606 2PK IPC VISAO FDA UDI
- Model / Reference
- 3318606 FDA UDI
- Description
- COOLING SET 3318606 2PK IPC VISAO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20613994436355 FDA UDI
- 510(k) Number
- K081277 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Surgical irrigation tubing set, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Category: Surgical irrigation tubing set, single-use
Visao® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation tubing set, single-use.
- SuperFlow Tubing Set — ARMM INC. · Class II
- Irrigation Set — B. BRAUN MEDICAL INC. · Class II
- EndoGator Hybrid — MEDIVATORS INC. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- CODMAN® — Integra LifeSciences Switzerland Sàrl · Class II
- MIDAS REX MR8 — Medtronic Powered Surgical Solutions · Class II
- Endo-Flo — Davol Inc. · Class II
- AESCULAP — AESCULAP, INC. · Class II
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.
- Integrated Power Console — 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 c5b4beb4-c492-421b-abf2-fa26051838c3 35 fields · synced May 30, 2026