OVUMPICK

Basic Information

• Brand Name: OVUMPICK
• Primary DI: 00812261016535
• Version / Model: OVUMPICK - Double Lumen Ovum Pickup Needle 16G, 35cm
• Catalog Number: OVM-DL 16/35
• Company Name: ALLWIN MEDICAL DEVICES, INC.
• Labeler DUNS: 796354509
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-18
• Public Version: 1
• Public Version Date: 2020-09-28
• Public Version Status: New
• Public Device Record Key: 0a1a84a1-3735-43af-9a8c-a7666f3a1601

Device Description

OVUMPICK - Double Lumen Ovum Pickup Needle 16G, 35cm

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: Yes
• 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	10812261016532	GS1		10	In Commercial Distribution
Primary	00812261016535	GS1

Premarket Submissions

Submission Number	Supplement Number
K190590	000