Identity
- Trade Name
- VISAO™ FDA UDI
- Generic Name
- Surgical mist irrigation tip FDA UDI
- Device Name
- SLEEVE 3334610 VISAO IRRIGATION FDA UDI
- Model / Reference
- 3334610 FDA UDI
- Description
- SLEEVE 3334610 VISAO IRRIGATION FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885074107370 FDA UDI
- 510(k) Number
- K983224 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Surgical mist irrigation tip 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical mist irrigation tip
Visao™ by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical mist irrigation tip.
- Premium Plus — Premium Plus International Limited · Class I
- Premium Plus — Premium Plus International Limited · Class I
- Premium Plus — Premium Plus International Limited · Class I
- Simpulse — Davol Inc. · Class II
- Premium Plus — Premium Plus International Limited · Class I
- EndoWrist — Intuitive Surgical, Inc. · Class II
- HI-LINE XS — AESCULAP, INC. · Class I
- Juneland — Suzhou Juneland Medical Co., Ltd. · Class II
Cleared under the same submission
K983224 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI 723e9dcb-9af7-4d38-b640-4fea2b993a85 35 fields · synced Jun 6, 2026