Identity
- Trade Name
- V-GRAD 80 (2x for V-GRAD Kit) FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- V-GRD83_12G FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260650070181 FDA UDI
- 510(k) Number
- K241833 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- IVF medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: IVF medium
V-GRAD 80 (2x for V-GRAD Kit) by VITROMED GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- VITROMED GmbH
Sources (2)
- FDA UDI d9d0393d-1535-471f-b832-96ef82a57a03 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026