FDA.reportPublic FDA data

Embozene Microspheres (Opaque)

Primary DI
00879397003242
Brand
Embozene Microspheres (Opaque)
Company
CELONOVA BIOSCIENCES, INC.
Model
10710-S0
Device description
Microspheres for Embolization
Published
2015-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00879397003242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00879397003242008793970032428793970032420879397003242

GMDN Terms#

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

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter75Micrometer

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
168593429
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00879397000074Embozene Microspheres (Color-Advanced)111010-S12015-07-15
00879397000081Embozene Microspheres (Color-Advanced)111020-S12015-07-15
00879397000098Embozene Microspheres (Color-Advanced)113010-S12015-07-15
00879397000104Embozene Microspheres (Color-Advanced)113020-S12015-07-15
00879397000111Embozene Microspheres (Color-Advanced)10410-S12015-07-15
00879397000128Embozene Microspheres (Color-Advanced)10420-S12015-07-15
00879397000135Embozene Microspheres (Color-Advanced)10710-S12015-07-15
00879397000142Embozene Microspheres (Color-Advanced)10720-S12015-07-15
00879397000241ONCOZENE Microspheres 10420-US12015-07-15
00879397000258ONCOZENE Microspheres10430-US12015-07-15
00879397000265ONCOZENE Microspheres 10720-US12015-07-15
00879397000272ONCOZENE Microspheres 10730-US12015-07-15
00879397000289ONCOZENE Microspheres11020-US12015-07-15
00879397000296ONCOZENE Microspheres11030-US12015-07-15
00879397001118Embozene Microspheres (Color-Advanced)11010-S12015-07-15
00879397001125Embozene Microspheres (Color-Advanced)11020-S12015-07-15
00879397002115Embozene Microspheres (Color-Advanced)12010-S12015-07-15
00879397002122Embozene Microspheres (Color-Advanced)12020-S12015-07-15
00879397003228Embozene Microspheres (Opaque)10410-S02015-07-15
00879397003235Embozene Microspheres (Opaque)10420-S02015-07-15

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