Occlusin 500

GUDID 07540270000056

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 (

IMBiotechnologies Ltd

Embolization particle, bioabsorbable
Primary Device ID07540270000056
NIH Device Record Key8f3e2743-d861-4ca9-9a1b-e5fe1c45d557
Commercial Distribution StatusIn Commercial Distribution
Brand NameOcclusin 500
Version Model NumberOCL 503L
Company DUNS244234295
Company NameIMBiotechnologies Ltd
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-780-945-6609
Emailcontact@imbiotechnologies.com
Phone1-780-945-6609
Emailcontact@imbiotechnologies.com
Phone1-780-945-6609
Emailcontact@imbiotechnologies.com
Phone1-780-945-6609
Emailcontact@imbiotechnologies.com
Phone1-780-945-6609
Emailcontact@imbiotechnologies.com
Phone1-780-945-6609
Emailcontact@imbiotechnologies.com
Phone1-780-945-6609
Emailcontact@imbiotechnologies.com
Phone1-780-945-6609
Emailcontact@imbiotechnologies.com
Phone1-780-945-6609
Emailcontact@imbiotechnologies.com
Phone1-780-945-6609
Emailcontact@imbiotechnologies.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location

Device Identifiers

Device Issuing AgencyDevice ID
GS107540270000056 [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 Date2019-02-25
Device Publish Date2019-01-24

On-Brand Devices [Occlusin 500]

07540270000070Occlusin 500 is a family of biodegradable dense microspheres which are available in a range of c
07540270000063Occlusin 500 is a family of biodegradable dense microspheres which are available in a range of c
07540270000056Occlusin 500 is a family of biodegradable dense microspheres which are available in a range of c
07540270000049Occlusin 500 is a family of biodegradable dense microspheres which are available in a range of c
07540270000032Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available
07540270000025Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available
07540270000018Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available

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