ViSAO®

FDA UDI

Class I (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: ViSAO® FDA UDI
Generic Name: Metal/carbide ENT bur, single-use FDA UDI
Device Name: BUR 31181098E VISAO 1MM 98 L 20DG DIAMD FDA UDI
Model / Reference: 31181098E FDA UDI
Description: BUR 31181098E VISAO 1MM 98 L 20DG DIAMD FDA UDI

Identifiers

Primary DI / UDI-DI: 00885074322216 FDA UDI
FDA Product Code: EQJ FDA UDI
GMDN Term: Metal/carbide ENT bur, single-use 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 98.0 Millimeter FDA UDI
Angle — 20.0 degree FDA UDI
Outer Diameter — 1.0 Millimeter FDA UDI

Category: Metal/carbide ENT bur, single-use

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

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OSSEOUS Burs-stainless Steel — EON MEDITECH PRIVATE LIMITED · Class I
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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 I	Pending data

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Manufacturer

Manufacturer: Medtronic Xomed, Inc.

Sources (1)

FDA UDI 9b10ceb8-e06f-4a0e-91c4-713d0ac16fd2 35 fields · synced May 30, 2026