Product Overview

Wallace - ONS1833


Device Description

A sterile, sharp bevel-edged, hollow tubular metal instrument specifically designed to penetrate ovarian follicles and aspirate oocytes (eggs) typically during the harvesting phase of an in vitro fertilization (IVF) procedure. The device may include aspiration tubing attached to its proximal end. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: MQE

Device Name: Needle, Assisted Reproduction

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OB

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 884.6100

Third Party Flag: Y

Medical Specialty: OB


Device Identifiers

Device Id: 35019315016848

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15019315016844

Package Quantity: 10

Package Discontinue Date: 9/27/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Box


Device Id: 15019315016844

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


Device Id: 55019315016842

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 35019315016848

Package Quantity: 100

Package Discontinue Date: 9/27/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Carton


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