Embosphere Pro™

GUDID 10884450299446

BIOSPHERE MEDICAL

Embolization particle, non-bioabsorbable
Primary Device ID10884450299446
NIH Device Record Key09b72693-7de5-413b-8441-700b2269f08b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmbosphere Pro™
Version Model Number00884450299449
Company DUNS635091932
Company NameBIOSPHERE MEDICAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100884450299449 [Primary]
GS110884450299446 [Package]
Contains: 00884450299449
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NOYAgents, embolic, for treatment of benign prostatic hyperplasia

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-16

On-Brand Devices [Embosphere Pro™]

0088445029945600884450299456
1088445029944600884450299449

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