OPU Needle

FDA UDI

Class II (US FDA UDI)

by Kitazato Corporation

Identity

Trade Name: OPU Needle FDA UDI
Generic Name: IVF oocyte aspiration needle, single-use FDA UDI
Device Name: 1 Packs FDA UDI
Model / Reference: OPU Needle FDA UDI
Description: 1 Packs FDA UDI

Identifiers

Catalog Number: 359364 FDA UDI
Primary DI / UDI-DI: 04580745043730 FDA UDI
510(k) Number: K162881 FDA UDI
FDA Product Code: MQE FDA UDI
GMDN Term: IVF oocyte aspiration needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6100 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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: IVF oocyte aspiration needle, single-use

OPU Needle by Kitazato Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as IVF oocyte aspiration needle, single-use.

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Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class II
Follicle Aspiration Set Double Lumen — Vitrolife Sweden AB · Class II
16G Wallace Dual Lumen Oocyte Recovery Set — CooperSurgical, Inc. · Class II
17G Wallace Dual Lumen Oocyte Recovery Set — CooperSurgical, Inc. · Class II
18G Wallace Single Lumen Oocyte Recovery Set — CooperSurgical, Inc. · Class II
16G Wallace Single Lumen Oocyte Recovery Set — CooperSurgical, Inc. · 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: Kitazato Corporation

Sources (1)

FDA UDI 725683b3-e1f2-4a18-88df-106d51c5c936 36 fields · synced May 30, 2026