Wallace - ON1733
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 IdentifiersDevice Id: 35019315047064
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15019315047060
Package Quantity: 10
Package Discontinue Date: 9/27/2019 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Box
Device Id: 15019315047060
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: 55019315047068
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 35019315047064
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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