Olympus

FDA UDI

Class II (US FDA UDI)

by Olympus Winter & Ibe GmbH

Identity

Trade Name: Olympus FDA UDI
Generic Name: Orthopaedic implantation sleeve, reusable FDA UDI
Device Name: Shaft "HiQ+", 10 x 330 mm, insulated FDA UDI
Model / Reference: A60900A FDA UDI
Description: Shaft "HiQ+", 10 x 330 mm, insulated FDA UDI

Identifiers

Catalog Number: A60900A FDA UDI
Primary DI / UDI-DI: 04042761009867 FDA UDI
510(k) Number: K944200 FDA UDI
K944201 FDA UDI
FDA Product Code: GCJ FDA UDI
HET FDA UDI
GMDN Term: Orthopaedic implantation sleeve, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
884.1720 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

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

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Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implantation sleeve, reusable

Olympus by Olympus Winter & Ibe GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implantation sleeve, reusable.

Arthrex® — Arthrex, Inc. · Class I
gSource — GSOURCE, LLC. · Class I
FITBONE TAA SYSTEM — Orthofix, Inc. · Class II
RIGID SUPRA ENTRY SLEEVE 13MM — Zimmer, Inc. · Class I
Jet-X — Smith & Nephew, Inc. · Class II
Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class I
Salvo® Spine System — Spine Wave, Inc. · Class I
DRILL SLEEVE — Biomet Orthopedics, Inc. · Class I

Cleared under the same submission

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: Olympus Winter & Ibe GmbH

Sources (1)

FDA UDI 2ea27508-2ca2-423d-ae84-badfbd7f37a6 36 fields · synced May 30, 2026