Embosphere®

FDA UDI

Class II (US FDA UDI)

by Biosphere Medical, Inc.

Identity

Trade Name: Embosphere® FDA UDI
Generic Name: Embolization particle, non-bioabsorbable FDA UDI
Model / Reference: 00884450403440 FDA UDI

Identifiers

Catalog Number: S620GH/C FDA UDI
Primary DI / UDI-DI: 00884450403440 FDA UDI
FDA Product Code: KRD FDA UDI
HCG FDA UDI
NAJ FDA UDI
NOY FDA UDI
GMDN Term: Embolization particle, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3300 FDA UDI
882.5950 FDA UDI
876.5550 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

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Embolization particle, non-bioabsorbable

Embosphere® by Biosphere Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Embolization particle, non-bioabsorbable.

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Contour™ — Boston Scientific · Class II
Embozene® — Boston Scientific · Class II
Embozene Microspheres (Opaque) — Celonova Biosciences, Inc. · Class II
Embozene Microspheres (Color-Advanced) — Celonova Biosciences, Inc. · Class II
HydroPearl — MICROVENTION INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biosphere Medical, Inc.

Sources (1)

FDA UDI 5301a300-c199-40b4-951f-34e9c9c26715 34 fields · synced May 30, 2026