SIR-Spheres Delivery Apparatus

GUDID 00850014612047

Delivery Apparatus for the administration of SIR-Spheres

SIRTEX MEDICAL PTY LTD

Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose Radiation shielding container, general-purpose
Primary Device ID00850014612047
NIH Device Record Keyf861ef70-b387-4441-a544-15514c771cf3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIR-Spheres Delivery Apparatus
Version Model NumberSIR-B001
Company DUNS755092467
Company NameSIRTEX MEDICAL PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailqa@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850014612047 [Primary]

FDA Product Code

KPYShield, Protective, Personnel

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-22
Device Publish Date2021-07-14

Devices Manufactured by SIRTEX MEDICAL PTY LTD

00850014612146 - SIR-Spheres Select Y-90 resin microspheres2024-04-05 SIR-Y002 (1.8Gbq/3ml): SIR-Spheres Select Y-90 resin microspheres, also called SIR-Spheres Select, consist of biocompatible resi
00850014612108 - SIR-Spheres® Microspheres Activity Calculator (SMAC)2021-08-24 Dose activity calculator for Selective Internal Radiation Therapy (SIRT)
00850014612061 - SIR-Spheres V-Vial2021-07-23 SIR-Spheres V-Vial
00850014612047 - SIR-Spheres Delivery Apparatus2021-07-22Delivery Apparatus for the administration of SIR-Spheres
00850014612047 - SIR-Spheres Delivery Apparatus2021-07-22 Delivery Apparatus for the administration of SIR-Spheres
00850014612054 - SIR-Spheres Delivery Set 2021-07-22 Sir-Spheres delivery set
00850014612078 - SIR-Spheres V-Vial Holder2021-07-22 SIR-Spheres V-Vial Holder
00850014612092 - SIR-Spheres Accessories Pack2021-07-22 Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder)
00850014612085 - SIR-Spheres Syringe Shield2021-07-19 SIR-Spheres Syringe Shield
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