Embozene Microspheres (Opaque)

GUDID 00879397003259

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 ID00879397003259
NIH Device Record Keyf8547a18-c0eb-49d2-b60c-e51791fbda34
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmbozene Microspheres (Opaque)
Version Model Number10720-S0
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 Diameter75 Micrometer
Outer Diameter75 Micrometer
Outer Diameter75 Micrometer
Outer Diameter75 Micrometer
Outer Diameter75 Micrometer
Outer Diameter75 Micrometer
Outer Diameter75 Micrometer
Outer Diameter75 Micrometer
Outer Diameter75 Micrometer
Outer Diameter75 Micrometer

Device Identifiers

Device Issuing AgencyDevice ID
GS100879397003259 [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

On-Brand Devices [Embozene Microspheres (Opaque)]

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00879397003358Microspheres for Embolization
00879397003341Microspheres for Embolization
00879397003334Microspheres for Embolization
00879397003327Microspheres for Embolization
00879397003310Microspheres for Embolization
00879397003303Microspheres for Embolization
00879397003297Microspheres for Embolization
00879397003280Microspheres for Embolization
00879397003273Microspheres for Embolization
00879397003266Microspheres for Embolization
00879397003259Microspheres for Embolization
00879397003242Microspheres for Embolization
00879397003235Microspheres for Embolization
00879397003228Microspheres for Embolization

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