Wallace

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Wallace FDA UDI
Generic Name: IVF oocyte aspiration needle, single-use FDA UDI
Model / Reference: ONS1633LL-500 FDA UDI

Identifiers

Primary DI / UDI-DI: 15019315059278 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: IVF oocyte aspiration needle, single-use

Wallace by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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16G Wallace Dual Lumen Oocyte Recovery Set — CooperSurgical, Inc. · Class II
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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: Icu Medical, Inc.

Sources (1)

FDA UDI f10f7bb6-6b48-4359-81ef-222fc1905bf8 32 fields · synced Jun 1, 2026