Follicle Aspiration needle - single lumen

GUDID 25425017505840

Transvaginal harvesting of oocytes from follicles for IVF and ICSI.

Gynetics Medical Products NV

IVF oocyte aspiration needle, single-use

• Primary Device ID: 25425017505840
• NIH Device Record Key: 056c5d04-d074-49b0-ad70-6da00519a83e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Follicle Aspiration needle - single lumen
• Version Model Number: #4551 FAS XD-BCB2
• 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	05425017505846 [Primary]
GS1	15425017505843 [Package]; Contains: 05425017505846; Package: [25 Units]; In Commercial Distribution
GS1	25425017505840 [Package]; Contains: 05425017505846; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013497

FDA Product Code

• MQE: Needle, Assisted Reproduction

Sterilization

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

[25425017505840]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-03

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• 25425017502016 - Intrauterine insemination cannula: 2019-01-23 Intra uterine Artificial Insemination
• 25425017502023 - Intrauterine insemination cannula: 2019-01-23 Intrauterine insemination cannula
• 25425017502030 - Intrauterine insemination cannula: 2019-01-23 Intrauterine insemination cannula
• 25425017502047 - Intrauterine insemination cannula: 2019-01-23 Intrauterine insemination cannula
• 25425017502054 - Intrauterine insemination cannula: 2019-01-23 Intrauterine insemination cannula
• 25425017502061 - Intrauterine insemination cannula: 2019-01-23 Intrauterine insemination cannula