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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 312120115E VISAO 2MM 115L 20D CRS DM FDA UDI
Model / Reference
312120115E FDA UDI
Description
BUR 312120115E VISAO 2MM 115L 20D CRS DM FDA UDI

Identifiers

Primary DI / UDI-DI
00885074322254 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

Yes

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
Angle — 20.0 degree FDA UDI
Outer Diameter — 2.0 Millimeter 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.

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 b8a8a2c7-f3b9-4786-9335-d697ff642139 35 fields · synced May 31, 2026