FDA.reportPublic FDA data

Occlusin 500

Primary DI
07540270000063
Brand
Occlusin 500
Company
IMBiotechnologies Ltd
Model
Ekobi 504
Device description
Occlusin 500 is a family of biodegradable dense microspheres which are available in a range of calibrated sizes. The poly-DL-lactic-co-glycolic acid (PLGA) microspheres are surface-coated with bovine collagen. Following injection, the collagen binds patient platelets resulting in a platelet-rich clot which occludes the vasculature. The microspheres slowly degrade and are removed from the body over 4-6 months.
Published
2019-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K093813000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093813000OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICEImbiotechnologies2010-05-10KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540270000063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540270000063075402700000637540270000063

GMDN Terms#

Term, Definition table
TermDefinition
Embolization particle, bioabsorbableA sterile, bioabsorbable, implantable bead/microsphere intended to be used to temporarily occlude an artery supplying hyperplastic/neoplastic tissue in a variety of anatomies (e.g., liver, lung, breast, bladder, uterus, head or neck); it does not include a pharmaceutical agent. It may be used independently to create ischemia in the tissue, or as an adjuvant in combination with cytostatic agents and other antitumour drugs to help optimize intra-tumour drug accumulation for interventional radiology and visceral surgery procedures. It is typically available as an injectable solution containing numerous microspheres [e.g., degradable starch microspheres (DSM)]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry location

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-780-945-6609contact@imbiotechnologies.com

Regulatory Flags#

DUNS number
244234295
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540270000018Occlusin 500Ekobi 5012019-05-22
07540270000025Occlusin 500Ekobi 5022019-05-22
07540270000032Occlusin 500Ekobi 5032019-05-22
07540270000049Occlusin 500Ekobi 503P2019-01-24
07540270000056Occlusin 500Ekobi 503L2019-01-24
07540270000070Occlusin 500Ekobi 5052018-08-10

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