Embozene Microspheres (Color-Advanced)

GUDID 00879397005116

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 ID00879397005116
NIH Device Record Keyee6cdfc3-a7cc-4be6-9442-6a337a018401
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmbozene Microspheres (Color-Advanced)
Version Model Number15010-S1
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 Diameter500 Micrometer
Outer Diameter500 Micrometer
Outer Diameter500 Micrometer
Outer Diameter500 Micrometer
Outer Diameter500 Micrometer
Outer Diameter500 Micrometer
Outer Diameter500 Micrometer
Outer Diameter500 Micrometer
Outer Diameter500 Micrometer
Outer Diameter500 Micrometer

Device Identifiers

Device Issuing AgencyDevice ID
GS100879397005116 [Primary]

FDA Product Code

NAJAgents,Embolic,For Treatment Of Uterine Fibroids

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

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00879397000111Microspheres for Embolization
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