Intrauterine insemination cannula

Basic Information

• Brand Name: Intrauterine insemination cannula
• Primary DI: 05425017502005
• Version / Model: #4220 IUI
• Company Name: Gynetics Medical Products NV
• Labeler DUNS: 283088573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-03
• Public Version: 5
• Public Version Date: 2019-01-23
• Public Version Status: Update
• Public Device Record Key: 7dbd879a-497e-484c-9485-aa5b8da6a3c4

Device Description

Intra uterine Artificial Insemination

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: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	884.6110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45846	Assisted reproduction transfer catheter/set	A device or collection of devices that includes a flexible polymer tube intended to be used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)]. In addition to the ‘live transfer’ catheter it may also include a trial transfer catheter intended to assess/ensure that embryo placement will be successful; it typically also includes devices intended to assist catheter introduction (e.g., outer guide sheath, stylet). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	25425017502009	GS1		125	In Commercial Distribution
Primary	05425017502005	GS1
Package	15425017502002	GS1		25	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K013501	000

Device Sizes

Type	Value	Unit	Text
Length	206	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 30 Degrees Celsius