Bead Block 900-1200

GUDID 05060116920093

Embolic spheres

BIOCOMPATIBLES UK LTD

Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable
Primary Device ID05060116920093
NIH Device Record Key8cb1285c-f126-4169-9ed0-7d3b6e1825b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameBead Block 900-1200
Version Model NumberEB2S912
Company DUNS222870839
Company NameBIOCOMPATIBLES UK 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

Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com
Phone+4401252732732
Emailmedical.services@btgplc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105060116920093 [Primary]

FDA Product Code

HCGDevice, Neurovascular Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-06-27
Device Publish Date2015-10-05

Devices Manufactured by BIOCOMPATIBLES UK LTD

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05060116921380 - TheraSphere Y90 Glass Microspheres 3.5 GBq (US Commercial)2020-06-29 TheraSphere Yttrium-90 Glass Microspheres 3.5 GBq Dose (US Commercial)
05060116921397 - TheraSphere Y90 Glass Microspheres 4.0 GBq (US Commercial)2020-06-29 TheraSphere Yttrium-90 Glass Microspheres 4.0 GBq Dose (US Commercial)
05060116921403 - TheraSphere Y90 Glass Microspheres 4.5 GBq (US Commercial)2020-06-29 TheraSphere Yttrium-90 Glass Microspheres 4.5 GBq Dose (US Commercial)
05060116921410 - TheraSphere Y90 Glass Microspheres 5.0 GBq (US Commercial)2020-06-29 TheraSphere Yttrium-90 Glass Microspheres 5.0 GBq Dose (US Commercial)
05060116921427 - TheraSphere Y90 Glass Microspheres 5.5 GBq (US Commercial)2020-06-29 TheraSphere Yttrium-90 Glass Microspheres 5.5 GBq Dose (US Commercial)
05060116921434 - TheraSphere Y90 Glass Microspheres 6.0 GBq (US Commercial)2020-06-29 TheraSphere Yttrium-90 Glass Microspheres 6.0 GBq Dose (US Commercial)

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