← Back to catalogue

ONCOZENE 100um Oncozene 2mL - US

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems, Inc

Identity

Trade Name
ONCOZENE 100um Oncozene 2mL - US FDA UDI
Generic Name
Embolization particle, non-bioabsorbable FDA UDI
Model / Reference
11020-US1 FDA UDI

Identifiers

Primary DI / UDI-DI
00810563021462 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 100um Oncozene 2mL - 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

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

Manufacturer

Manufacturer
Varian Medical Systems, Inc

Sources (1)

  • FDA UDI d8c21b83-2512-4372-9814-62d6d96a1357 33 fields · synced May 30, 2026