AccessGUDID - DEVICE: ONCOZENE 75um Oncozene 2mL

GUDID

Device Identifier (DI) Information

Brand Name: ONCOZENE 75um Oncozene 2mL - US
Version or Model: 10720-US1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Varian Medical Systems, Inc.

Primary DI Number: 00810563021448
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118097024 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60938	Embolization particle, non-bioabsorbable	A non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs); it does not include a pharmaceutical agent. It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KRD	Device, Vascular, for Promoting Embolization
NAJ	Agents, embolic, for treatment of uterine fibroids

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141209	000
K242794	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bc47c6b1-2a05-4921-8cee-354f9115db4d
Public Version Date: October 06, 2025
Public Version Number: 3
DI Record Publish Date: May 19, 2023