16G Wallace Single Lumen Oocyte Recovery Set

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: 16G Wallace Single Lumen Oocyte Recovery Set FDA UDI
Generic Name: IVF oocyte aspiration needle, single-use FDA UDI
Device Name: 16G Wallace Single Lumen Oocyte Recovery Set, 500 mm tubing (Box of 10) FDA UDI
Model / Reference: ONS1633-500 FDA UDI
Description: 16G Wallace Single Lumen Oocyte Recovery Set, 500 mm tubing (Box of 10) FDA UDI

Identifiers

Primary DI / UDI-DI: 00888937021059 FDA UDI
FDA Product Code: KOC FDA UDI
GMDN Term: IVF oocyte aspiration needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5820 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

FDA UDI

Dimensions & Sizes

Size: Length — 500 Millimeter FDA UDI
Needle Gauge — 16 Gauge FDA UDI

Category: IVF oocyte aspiration needle, single-use

16G Wallace Single Lumen Oocyte Recovery Set by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: CooperSurgical, Inc.

Sources (1)

FDA UDI 9fb5d224-3b3d-487f-a35d-1b6a9b99211d 34 fields · synced Jun 9, 2026