16G Wallace Dual Lumen Oocyte Recovery Set

Basic Information

• Brand Name: 16G Wallace Dual Lumen Oocyte Recovery Set
• Primary DI: 00888937020908
• Version / Model: DNS1633-750
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-04
• Public Version: 3
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: d34fecf8-3938-4c8c-8b6c-e270e1220331

Device Description

16G Wallace Dual Lumen Oocyte Recovery Set, 750 mm tubing (Box 10)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	884.6100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45676	IVF oocyte aspiration needle, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30888937020909	GS1	Case	10	In Commercial Distribution
Package	20888937020902	GS1	Box	10	In Commercial Distribution
Primary	00888937020908	GS1

Device Sizes

Type	Value	Unit	Text
Length	750	Millimeter
Needle Gauge	16	Gauge