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Embozene Microspheres (Opaque)

FDA UDI

Class II (US FDA UDI)

by Celonova Biosciences, Inc.

Identity

Trade Name
Embozene Microspheres (Opaque) FDA UDI
Generic Name
Embolization particle, non-bioabsorbable FDA UDI
Device Name
Microspheres for Embolization FDA UDI
Model / Reference
10720-S0 FDA UDI
Description
Microspheres for Embolization FDA UDI

Identifiers

Primary DI / UDI-DI
00879397003259 FDA UDI
FDA Product Code
NAJ FDA UDI
KRD FDA UDI
GMDN Term
Embolization particle, non-bioabsorbable 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

Dimensions & Sizes

Size
Outer Diameter — 75 Micrometer FDA UDI

Category: Embolization particle, non-bioabsorbable

Embozene Microspheres (Opaque) by Celonova Biosciences, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Embolization particle, non-bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Celonova Biosciences, Inc.

Sources (1)

  • FDA UDI f8547a18-c0eb-49d2-b60c-e51791fbda34 34 fields · synced May 31, 2026