ONCOZENE 40um Oncozene 3mL - US

GUDID 00810563021431

VARIAN MEDICAL SYSTEMS, INC.

Embolization particle, non-bioabsorbable
Primary Device ID00810563021431
NIH Device Record Keya64a32a6-48f0-4ffa-867f-70b862d291f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameONCOZENE 40um Oncozene 3mL - US
Version Model Number10430-US1
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Identifiers

Device Issuing AgencyDevice ID
GS100810563021431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRDDevice, Vascular, for Promoting Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-29
Device Publish Date2023-05-19

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