ONCOZENE Microspheres

GUDID 00879397000289

Microspheres for Embolization

CELONOVA BIOSCIENCES, INC.

Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable
Primary Device ID00879397000289
NIH Device Record Keyef05aa10-928c-49b7-ad1e-e97d061a1dd4
Commercial Distribution StatusIn Commercial Distribution
Brand NameONCOZENE Microspheres
Version Model Number11020-US1
Company DUNS168593429
Company NameCELONOVA BIOSCIENCES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter100 Micrometer
Outer Diameter100 Micrometer
Outer Diameter100 Micrometer
Outer Diameter100 Micrometer
Outer Diameter100 Micrometer
Outer Diameter100 Micrometer
Outer Diameter100 Micrometer
Outer Diameter100 Micrometer
Outer Diameter100 Micrometer
Outer Diameter100 Micrometer

Device Identifiers

Device Issuing AgencyDevice ID
GS100879397000289 [Primary]

FDA Product Code

KRDDevice, Vascular, For Promoting Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-07-15

On-Brand Devices [ONCOZENE Microspheres]

00879397000296Microspheres for Embolization
00879397000289Microspheres for Embolization
00879397000272Microspheres for Embolization
00879397000265Microspheres for Embolization
00879397000258Microspheres for Embolization
00879397000241Microspheres for Embolization

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