Follicle Aspiration Set, Single Lumen

Basic Information

• Brand Name: Follicle Aspiration Set, Single Lumen
• Primary DI: 07350025914244
• Version / Model: 14169
• Company Name: Vitrolife Sweden AB
• Labeler DUNS: 631805488
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 4
• Public Version Date: 2019-11-28
• Public Version Status: Update
• Public Device Record Key: 01aacc91-412c-49e6-91fd-357fcfc477c6
• Distribution End Date: 2019-11-27

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: No
• 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	17350025914241	GS1		10	Not in Commercial Distribution	2019-11-27
Primary	07350025914244	GS1

Premarket Submissions

Submission Number	Supplement Number
K991273	000