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ONCOZENE 40um Oncozene 3mL - US

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems, Inc

Identity

Trade Name
ONCOZENE 40um Oncozene 3mL - US FDA UDI
Generic Name
Embolization particle, non-bioabsorbable FDA UDI
Model / Reference
10430-US1 FDA UDI

Identifiers

Primary DI / UDI-DI
00810563021431 FDA UDI
510(k) Number
K141209 FDA UDI
K242794 FDA UDI
FDA Product Code
KRD FDA UDI
NAJ 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
MRI Safety
MR Safe FDA UDI

Category: Embolization particle, non-bioabsorbable

ONCOZENE 40um Oncozene 3mL - US by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Embolization particle, non-bioabsorbable.

Cleared under the same submission

K141209 also covers:

K242794 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Varian Medical Systems, Inc

Sources (1)

  • FDA UDI a64a32a6-48f0-4ffa-867f-70b862d291f1 33 fields · synced Jun 7, 2026