SIR-Spheres Syringe Shield

GUDID 00850014612085

Syringe radiation shield

Primary Device ID	00850014612085
NIH Device Record Key	9c37f2e5-9f08-49f3-9a51-edaae0f38e33
Commercial Distribution Status	In Commercial Distribution
Brand Name	SIR-Spheres Syringe Shield
Version Model Number	SIR-S001
Company DUNS	755092467
Company Name	SIRTEX MEDICAL PTY LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00850014612085 [Primary]

IWR	Holder, Syringe, Lead

Steralize Prior To Use	false
Device Is Sterile	false

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00850014612146 - SIR-Spheres Select Y-90 resin microspheres	2024-04-05 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-Vial	2021-07-23 SIR-Spheres V-Vial
00850014612047 - SIR-Spheres Delivery Apparatus	2021-07-22 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 Holder	2021-07-22 SIR-Spheres V-Vial Holder
00850014612092 - SIR-Spheres Accessories Pack	2021-07-22 Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder)