V-GRAD 100

Basic Information

• Brand Name: V-GRAD 100
• Primary DI: 04260650071201
• Version / Model: V-GRD00_100P
• Company Name: VITROMED GmbH
• Labeler DUNS: 315234102
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-03
• Public Version: 1
• Public Version Date: 2025-07-11
• Public Version Status: New
• Public Device Record Key: dfc18d00-6cf9-4cd4-a9ee-a655e5640fc1

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQL	Media, Reproductive	Obstetrics/Gynecology	884.6180	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44046	IVF medium	A solution that provides a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260650071201	GS1

Premarket Submissions

Submission Number	Supplement Number
K241833	000