SpermFilter Ready-to-use gradient 80% USA

GUDID 08719747531686

SpermFilter® Ready-to-use gradients USA (80% and 45%) are ready to use gradient systems for semen preparation. The SpermFilter® Ready-to-use system can be used for semen preparation for Intra Uterine Insemination (IUI), In Vitro Fertilization (IVF) and IntraCytoplasmatic Sperm Injection (ICSI).

Gynotec.B.V.

IVF medium

• Primary Device ID: 08719747531686
• NIH Device Record Key: f0e36e24-da99-4417-a8f4-60e22e94a39b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpermFilter Ready-to-use gradient 80% USA
• Version Model Number: SPF80-USA-0100
• Company DUNS: 489854382
• Company Name: Gynotec.B.V.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Dimensions

• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719747531679 [Primary]
GS1	08719747531686 [Package]; Contains: 08719747531679; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053494

FDA Product Code

• MQL: Media, Reproductive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-27
• Device Publish Date: 2026-01-19

On-Brand Devices [SpermFilter Ready-to-use gradient 80% USA]

• 08719747531822: SpermFilter® Ready-to-use gradients USA (80% and 45%) are ready to use gradient systems for sem
• 08719747531808: SpermFilter® Ready-to-use gradients USA (80% and 45%) are ready to use gradient systems for sem
• 08719747531709: SpermFilter® Ready-to-use gradients USA (80% and 45%) are ready to use gradient systems for sem
• 08719747531686: SpermFilter® Ready-to-use gradients USA (80% and 45%) are ready to use gradient systems for sem