Follicle Aspiration needle - single lumen flush

GUDID 25425017503228

Transvaginal harvesting of oocytes from follicles for IVF and ICSI.

Gynetics Medical Products NV

IVF oocyte aspiration needle, single-use

• Primary Device ID: 25425017503228
• NIH Device Record Key: 48b9581b-e2e6-4bf5-bf65-884e20425b4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Follicle Aspiration needle - single lumen flush
• Version Model Number: #4551 FAS FD
• 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	05425017503224 [Primary]
GS1	15425017503221 [Package]; Contains: 05425017503224; Package: [25 Units]; In Commercial Distribution
GS1	25425017503228 [Package]; Contains: 05425017503224; 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

[25425017503228]

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

Devices Manufactured by Gynetics Medical Products NV

• 05425017501022 - Embryo transfer catheter: 2020-02-19 Embryo transfer catheter used for introduction of embryos into the uterine cavity.
• 25425017502009 - Intrauterine insemination cannula: 2019-01-23 Intra uterine Artificial Insemination
• 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