Easi-Vue embolic microspheres System EVR100

GUDID 10850042341053

ABK Biomedical Incorporated

Embolization particle, non-bioabsorbable
Primary Device ID10850042341053
NIH Device Record Keycf035a0d-ed87-408a-b23b-4e24d89e0da3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasi-Vue embolic microspheres System
Version Model NumberRefill Syringe 100 micron
Catalog NumberEVR100
Company DUNS203463617
Company NameABK Biomedical Incorporated
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850042341056 [Primary]
GS110850042341053 [Package]
Contains: 00850042341056
Package: Carton [5 Units]
In Commercial Distribution

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 Date2022-11-01
Device Publish Date2022-10-24

On-Brand Devices [Easi-Vue embolic microspheres System]

10850042341060Refill Syringe 150 micron
10850042341053Refill Syringe 100 micron
10850042341046Refill Syringe 50 micron
00850042341032Administration Kit 150 micron
00850042341025Administration Kit 100 micron
00850042341018Administration Kit 50 micron
10850042341107EVD150
10850042341091EVD100
00850042341087EVD50

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