Oto-Flex

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: Oto-Flex FDA UDI
Generic Name: Metal/carbide ENT bur, reusable FDA UDI
Device Name: PERFORATOR 3155623 OTO-FLEX .35MM FDA UDI
Model / Reference: 3155623 FDA UDI
Description: PERFORATOR 3155623 OTO-FLEX .35MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000035891 FDA UDI
FDA Product Code: ERL FDA UDI
EQJ FDA UDI
GMDN Term: Metal/carbide ENT bur, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.4250 FDA UDI
874.4140 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

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: Outer Diameter — 0.35 Millimeter FDA UDI

Category: Metal/carbide ENT bur, reusable

Oto-Flex by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metal/carbide ENT bur, reusable.

Gyrus ACMI — Gyrus Acmi, Inc. · Class I
Tungst.Carb.Burr, Ø1.4x70mm, 50k — Bien-Air Surgery SA · Class I
Bur PM2-70 50K Steel Ø4.0 — Bien-Air Surgery SA · Class I
GYRUS ACMI — Gyrus Acmi, Inc. · Class I
Bur PM2-70 50K Carb Ø0.5 — Bien-Air Surgery SA · Class I
GYRUS ACMI — Gyrus Acmi, Inc. · Class I
GYRUS ACMI — Gyrus Acmi, Inc. · Class I
Bur PM2-70 50K Carb Ø6.0 — Bien-Air Surgery SA · Class I

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

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Manufacturer

Manufacturer: Medtronic Xomed, Inc.

Sources (1)

FDA UDI 980e41e0-7391-4fc4-890d-7df79ae9c53b 35 fields · synced Jun 1, 2026