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Gel-Bead™ Embolization Spheres

FDA UDI

Class II (US FDA UDI)

by Vascular Solutions, Inc.

Identity

Trade Name
Gel-Bead™ Embolization Spheres FDA UDI
Generic Name
Non-neurovascular embolization plug, animal-derived FDA UDI
Model / Reference
3821 FDA UDI

Identifiers

Primary DI / UDI-DI
M20638210 FDA UDI
FDA Product Code
KRD FDA UDI
GMDN Term
Non-neurovascular embolization plug, animal-derived FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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: Non-neurovascular embolization plug, animal-derived

Gel-Bead™ Embolization Spheres by Vascular Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-neurovascular embolization plug, animal-derived.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vascular Solutions, Inc.

Sources (1)

  • FDA UDI 895a4250-51d1-4dcb-b0a0-b2d7827882b4 34 fields · synced May 30, 2026