Embryo transfer catheter

GUDID 05425017501022

Embryo transfer catheter used for introduction of embryos into the uterine cavity.

Gynetics Medical Products NV

Assisted reproduction transfer catheter/set

• Primary Device ID: 05425017501022
• NIH Device Record Key: 76dab778-1d0d-4751-ac80-826d0073ba29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embryo transfer catheter
• Version Model Number: #4219 Emtrac Delphin
• Company DUNS: 283088573
• Company Name: Gynetics Medical Products NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3211645872
• Email: info@gynetics.com

Device Dimensions

• Total Volume: 0.23 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05425017501022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013536

FDA Product Code

• MQF: Catheter, Assisted Reproduction

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[05425017501022]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-19
• Device Publish Date: 2016-10-14

On-Brand Devices [Embryo transfer catheter ]

• 25425017501026: Embryo transfer catheter used for introduction of embryos into the uterine cavity.
• 25425017501415: Embryo transfer catheter used for introduction of embryos into the uterine cavity.
• 25425017501316: Embryo transfer catheter used for introduction of embryos into the uterine cavity.
• 05425017501053: Embryo transfer catheter used for introduction of embryos into the uterine cavity.
• 05425017501022: Embryo transfer catheter used for introduction of embryos into the uterine cavity.