Identity
- Trade Name
- VISAO® FDA UDI
- Generic Name
- Surgical power tool system control unit, pneumatic FDA UDI
- Device Name
- DRILL 3334800T VISAO IGS 80K HDPC ROHS FDA UDI
- Model / Reference
- 3334800T FDA UDI
- Description
- DRILL 3334800T VISAO IGS 80K HDPC ROHS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169360945 FDA UDI
- 510(k) Number
- K011321 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Surgical power tool system control unit, pneumatic 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: Surgical power tool system control unit, pneumatic
Visao® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical power tool system control unit, pneumatic.
- Triton® — Medtronic Powered Surgical Solutions · Class I
- Midas Rex — Medtronic Powered Surgical Solutions · Class II
- Triton® — Medtronic Powered Surgical Solutions · Class I
- MIDAS REX — Medtronic Powered Surgical Solutions · Class II
- Midas Rex — Medtronic Powered Surgical Solutions · Class II
- MIDAS REX STEALTH-MIDAS MR8 — Medtronic Powered Surgical Solutions · Class II
- MIDAS REX MR8 — Medtronic Powered Surgical Solutions · Class II
- Midas Rex® — Medtronic Powered Surgical Solutions · Class II
Cleared under the same submission
K011321 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 ab28f501-aba8-41d3-9c84-615dae6a0db1 35 fields · synced May 30, 2026