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Visao®

FDA UDI

Class I (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name
Visao® FDA UDI
Generic Name
Orthopaedic bur, reusable FDA UDI
Device Name
BUR 312140115E VISAO CVD 4MM 115L CR DMD FDA UDI
Model / Reference
312140115E FDA UDI
Description
BUR 312140115E VISAO CVD 4MM 115L CR DMD FDA UDI

Identifiers

Primary DI / UDI-DI
00613994223470 FDA UDI
510(k) Number
K041985 FDA UDI
FDA Product Code
EQJ FDA UDI
GMDN Term
Orthopaedic bur, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4140 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

Dimensions & Sizes

Size
Outer Diameter — 4.0 Millimeter FDA UDI
Angle — 18.0 degree FDA UDI
Length — 115.0 Millimeter FDA UDI

Category: Orthopaedic bur, reusable

Visao® by Medtronic Xomed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bur, reusable.

Cleared under the same submission

K041985 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI 3ac65291-aa6b-47b0-8d47-1c3801fcd287 36 fields · synced May 30, 2026