Skeeter®

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: SKEETER® FDA UDI
Generic Name: Bone/joint surgical power tool motor, electric FDA UDI
Device Name: DRILL 3055601 SKEETER OTO-TOOL ROHS FDA UDI
Model / Reference: 3055601 FDA UDI
Description: DRILL 3055601 SKEETER OTO-TOOL ROHS FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169882676 FDA UDI
510(k) Number: K833874 FDA UDI
FDA Product Code: ERL FDA UDI
GMDN Term: Bone/joint surgical power tool motor, electric FDA UDI

Classification

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

Clinical & Handling

Sterile

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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone/joint surgical power tool motor, electric

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

Similar devices

Also classified as Bone/joint surgical power tool motor, electric.

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Brasseler EZX — IMEDICOM CO., LTD. · Class I
Adler Instrument Company — Adler, Inc. · Class II
Midas Rex® — Medtronic Powered Surgical Solutions · Class II
Midas Rex® — Medtronic Powered Surgical Solutions · Class II
Brasseler EZX — IMEDICOM CO., LTD. · Class I
Brasseler EZX — IMEDICOM CO., LTD. · Class I
EZX — IMEDICOM CO., LTD. · Class I

Cleared under the same submission

K833874 also covers:

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 57cd0552-c217-4990-9281-bb7070e52eb4 36 fields · synced Jun 1, 2026