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EmboCube™

FDA UDI

Class II (US FDA UDI)

by Biosphere Medical, Inc.

Identity

Trade Name
EmboCube™ FDA UDI
Generic Name
Non-neurovascular embolization plug, animal-derived FDA UDI
Model / Reference
00884450306222 FDA UDI

Identifiers

Catalog Number
EC5025 FDA UDI
Primary DI / UDI-DI
00884450306222 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

No

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

EmboCube™ by Biosphere Medical, 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
Biosphere Medical, Inc.

Sources (1)

  • FDA UDI 912b4835-cab0-4c19-8696-1eb03095e589 34 fields · synced May 30, 2026