Intrauterine insemination cannula

GUDID 25425017502047

Intrauterine insemination cannula

Gynetics Medical Products NV

Assisted reproduction transfer catheter/set

• Primary Device ID: 25425017502047
• NIH Device Record Key: 8f568144-4df2-44ff-8967-4448e78e4c69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intrauterine insemination cannula
• Version Model Number: #4225 Smooze Long
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05425017502043 [Primary]
GS1	15425017502040 [Package]; Contains: 05425017502043; Package: [25 Units]; In Commercial Distribution
GS1	25425017502047 [Package]; Contains: 05425017502043; Package: [75 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013501

FDA Product Code

• MQF: Catheter, Assisted Reproduction

Sterilization

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

[25425017502047]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2017-01-17

On-Brand Devices [Intrauterine insemination cannula ]

• 15425017502088: Intrauterine insemination cannula
• 25425017502061: Intrauterine insemination cannula
• 25425017502054: Intrauterine insemination cannula
• 25425017502047: Intrauterine insemination cannula
• 25425017502030: Intrauterine insemination cannula
• 25425017502023: Intrauterine insemination cannula
• 25425017502016: Intra uterine Artificial Insemination
• 25425017502009: Intra uterine Artificial Insemination