← Back to catalogue

Embozene®

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
Embozene® FDA UDI
Generic Name
Embolization particle, non-bioabsorbable FDA UDI
Device Name
Microspheres for Embolization FDA UDI
Model / Reference
01-0301-00752-11 FDA UDI
Description
Microspheres for Embolization FDA UDI

Identifiers

Primary DI / UDI-DI
08714729942405 FDA UDI
FDA Product Code
KRD 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
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

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
MRI Safety
MR Safe FDA UDI

Category: Embolization particle, non-bioabsorbable

Embozene® by Boston Scientific — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 6b199803-bec8-4eb1-adfc-b14c0146831f 34 fields · synced Jun 8, 2026