Soft embryo transfer catheter

GUDID 25425017501071

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

Gynetics Medical Products NV

Assisted reproduction catheter set

• Primary Device ID: 25425017501071
• NIH Device Record Key: 26d56685-3f3f-40c3-991d-4db24848b2f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soft embryo transfer catheter
• Version Model Number: #2000 Semtrac Set 4.2
• 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	05425017501077 [Primary]
GS1	15425017501074 [Package]; Contains: 05425017501077; Package: [25 Units]; In Commercial Distribution
GS1	25425017501071 [Package]; Contains: 05425017501077; Package: [75 Units]; In Commercial Distribution

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

[25425017501071]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-14

On-Brand Devices [Soft embryo transfer catheter ]

• 25425017501118: Embryo transfer catheter used for introduction of embryos into the uterine cavity.
• 25425017501101: Embryo transfer catheter used for introduction of embryos into the uterine cavity.
• 25425017501088: Embryo transfer catheter used for introduction of embryos into the uterine cavity.
• 25425017501071: Embryo transfer catheter used for introduction of embryos into the uterine cavity.