Olympus

FDA UDI

Class II (US FDA UDI)

by Olympus Winter & Ibe GmbH

Identity

Trade Name: Olympus FDA UDI
Generic Name: Dissection forceps FDA UDI
Model / Reference: A64310S FDA UDI

Identifiers

Catalog Number: A64310S FDA UDI
Primary DI / UDI-DI: 04042761029957 FDA UDI
510(k) Number: K944200 FDA UDI
K944201 FDA UDI
FDA Product Code: GCJ FDA UDI
HET FDA UDI
GMDN Term: Dissection forceps 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dissection forceps

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

Similar devices

Also classified as Dissection forceps.

ARTHROFORCE / Take-Apart — Karl Storz GmbH & Co. KG · Class II
Straight Forceps, Straight Handle, 1x2 teeth, 210mm — KATALYST SURGICAL, LLC · Class I
Straight Forceps, Bayonet Handle, .5mm tips, 210mm — KATALYST SURGICAL, LLC · Class I
Ambler Surgical — Ambler Surgical, LLC · Class II
Curved Down Forceps, Bayonet Handle, .5mm tips, 210mm — KATALYST SURGICAL, LLC · Class I
ARTHROFORCE / Take-Apart — Karl Storz GmbH & Co. KG · Class II
Curved Up Forceps, Bayonet Handle, .5mm tips, 210mm — KATALYST SURGICAL, LLC · Class I
Ambler Surgical — Ambler Surgical, LLC · Class II

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 aad4407e-50b9-410c-b028-5f6dcc0f95e3 34 fields · synced Jun 1, 2026