Skimmer®

FDA UDI

Class I (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: Skimmer® FDA UDI
Generic Name: Diamond ENT bur, single-use FDA UDI
Device Name: BLADE 1882979HRE SKIMMER M4 13CM 2.9MM FDA UDI
Model / Reference: 1882979HRE FDA UDI
Description: BLADE 1882979HRE SKIMMER M4 13CM 2.9MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00613994233257 FDA UDI
FDA Product Code: EQJ FDA UDI
GMDN Term: Diamond 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: Outer Diameter — 2.9 Millimeter FDA UDI
Length — 13.0 Centimeter FDA UDI
Angle — 15.0 degree FDA UDI

Category: Diamond ENT bur, single-use

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

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Also classified as Diamond ENT bur, single-use.

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Bur PM2-125 80K Diam Ø4.0 St — Bien-Air Surgery SA · Class II
HS Diam. Burr, Ø2.0x70, 80k — Bien-Air Surgery SA · Class II
HS Dia.Bur, coarse, Ø4.0x150, 80k — 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 I	Pending data

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Manufacturer

Manufacturer: Medtronic Xomed, Inc.

Sources (1)

FDA UDI e3b3690c-1e26-4fa0-9731-b7c486ad97ee 35 fields · synced May 30, 2026