FDA.reportPublic FDA data

ONCOZENE 75um Oncozene 3mL - US

Primary DI
00810563021455
Brand
ONCOZENE 75um Oncozene 3mL - US
Company
Varian Medical Systems, Inc.
Model
10730-US1
Published
2023-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, for Promoting Embolization
NAJAgents, embolic, for treatment of uterine fibroids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2
NAJAgents, Embolic, For Treatment Of Uterine FibroidsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141209000
K242794000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141209000EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERESCelonova Biosciences, Inc.2014-08-07KRD
K242794000ONCOZENE MicrospheresVarian Medical Systems, Inc.2024-10-16KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810563021455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810563021455008105630214558105630214550810563021455

GMDN Terms#

Term, Definition table
TermDefinition
Embolization particle, non-bioabsorbableA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118097024
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinGM11014700GM110147002024-02-16
00810563022322Temperature Sensor Probe, 18G x 20cmABL-18TP202024-08-09
00816389029460Intrauterine tandem, 15 degrees, 2 cm, CT/ MRGM11012510GM110125102025-05-16
00816389029637Ovoid, 40 mm, pair, CT/ MRGM11012750GM110127502025-05-16
00816389029712Retractor, 30 mm, CT/ MRGM11012930GM110129302025-05-16
00816389020276Crook Prostate Template for 17 gauge (1.47 mm) needlesGM11012260GM110122602024-02-19
008105630209538mm CryoprobeDP35-0215-101CRYO-48-F2022-02-18
00810563020984MicroThermX Microwave Ablation System20-17222-001MTX-1802022-02-18
00810563020991MicroThermX Microwave Ablation System20-17222-101MTX180-T22022-02-18
008163890289062.4mm V-Probe™ CryoprobeDP35-0900-101CVA24002022-02-18
008163890289202.4mm V-Probe™ Cryoprobe Right AngleDP35-0902-108CVA2400RA2022-02-18
00816389028869VariSource VS2000 HDR Ir 192 Brachytherapy Sealed SourceAL09400000AL094000002022-01-09
00856104006000Varian Treatment13.02016-09-16
00856545006027VariSource iX1.2AL19004-0002016-09-16
00856545006034VariSource iX(t)1.2AL19004-0012016-09-16
00816389020986TANDEM ROTATE & SLIDE BLOCK (CT/MR FSD)AL10715008AL107150082016-09-19
00816389021686Intrauterine probe with stopper, angle 30 degrees, length 50 mmGM11000790GM110007902016-09-23
00816389021785Mini-colpostats, pairGM11000900GM110009002016-09-19
00816389022164Applicator probe 6/3 mm diameter, curved 15 degrees, length 320 mmGM110022302016-09-22
00816389022386Implant needle, 120 mm, 1.7 mm diameter, curvedGM11002930GM110029302016-09-23

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