V-GRAD 80 (2x for V-GRAD Kit)

GUDID 04260650070280

V- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is intended for separation of motile sperm from ejaculates for use in assisted reproduction procedures.

VITROMED GmbH

IVF medium

• Primary Device ID: 04260650070280
• NIH Device Record Key: d9d0393d-1535-471f-b832-96ef82a57a03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-GRAD 80 (2x for V-GRAD Kit)
• Version Model Number: V-GRD83_12G
• Company DUNS: 315234102
• Company Name: VITROMED GmbH
• 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: true
• Device Combination Product: false
• Single Use: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260650070181 [Primary]
GS1	04260650070280 [Package]; Contains: 04260650070181; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241833

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: 2025-07-11
• Device Publish Date: 2025-07-03

Devices Manufactured by VITROMED GmbH

• 04260650070082 - V-GRAD 40 (2x for V-GRAD Kit): 2025-07-11 V- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is i
• 04260650070280 - V-GRAD 80 (2x for V-GRAD Kit): 2025-07-11V- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is intended for separation of motile sperm from ejaculates for use in assisted reproduction procedures.
• 04260650070280 - V-GRAD 80 (2x for V-GRAD Kit): 2025-07-11 V- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is i
• 04260650070303 - V-GRAD 40: 2025-07-11 V- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is i
• 04260650071102 - V-GRAD 80: 2025-07-11 V- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is i
• 04260650071201 - V-GRAD 100: 2025-07-11 V- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is i
• 04260650070297 - V-VITWARM: 2024-11-25 V VITWARM is a ready-to-use kit to thaw human oocytes and embryos (up to blastocyst stage) which are cryopreserved. Subsequently
• 04260650070273 - V-VITFREEZE: 2024-10-24 V-VITFREEZE is a ready-to-use kit to cryopreserve human oocytes and embryos (up to blastocyst stage) in Assisted Reproduction Te
• 04260650071034 - V-PVP: 2024-05-13 V-PVP is a ready-to-use pharma grade polyvinylpyrrolidone (PVP) solution containing HEPES buffered Human Tubal Fluid (HTF) mediu