FDA.reportPublic FDA data

Easi-Vue embolic microspheres System

Primary DI
10850042341091
Brand
Easi-Vue embolic microspheres System
Company
ABK Biomedical Incorporated
Model
EVD100
Published
2024-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234123000Easi-Vue® embolic microspheres SystemAbk Biomedical, Inc.2024-02-13KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850042341091PackageGS13In Commercial Distribution
00850042341094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004234109110850042341091
00850042341094008500423410948500423410940850042341094

GMDN Terms#

Term, Definition table
TermDefinition
Embolization particle, non-bioabsorbableA non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs); it does not include a pharmaceutical agent. It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature16 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203463617
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850042341018Easi-Vue embolic microspheres SystemAdministration Kit 50 micronEVA502022-10-24
00850042341025Easi-Vue embolic microspheres SystemAdministration Kit 100 micronEVA1002022-10-24
00850042341032Easi-Vue embolic microspheres SystemAdministration Kit 150 micronEVA1502022-10-24
00850042341094Easi-Vue embolic microspheres SystemEVD1002024-03-12
00850042341100Easi-Vue embolic microspheres SystemEVD1502024-03-12
00850042341087Easi-Vue embolic microspheres SystemEVD502024-03-12
10850042341107Easi-Vue embolic microspheres SystemEVD1502024-03-12
00850042341049Easi-Vue embolic microspheres SystemRefill Syringe 50 micronEVR502022-10-24
00850042341056Easi-Vue embolic microspheres SystemRefill Syringe 100 micronEVR1002022-10-24
00850042341063Easi-Vue embolic microspheres SystemRefill Syringe 150 micronEVR1502022-10-24
10850042341046Easi-Vue embolic microspheres SystemRefill Syringe 50 micronEVR502022-10-24
10850042341053Easi-Vue embolic microspheres SystemRefill Syringe 100 micronEVR1002022-10-24
10850042341060Easi-Vue embolic microspheres SystemRefill Syringe 150 micronEVR1502022-10-24

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