FDA.reportPublic FDA data

SIR-Spheres Accessories Pack

Primary DI
00850014612092
Brand
SIR-Spheres Accessories Pack
Company
Sirtex Medical Inc.
Model
SIR-K002
Device description
Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder)
Published
2021-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWJSystem, Applicator, Radionuclide, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWJSystem, Applicator, Radionuclide, ManualRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014612092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014612092008500146120928500146120920850014612092

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose brachytherapy system applicator, manualA general-purpose brachytherapy applicator designed to facilitate delivery of radiation therapy treatments that are not specific to a particular anatomical region. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to facilitate the creation of variable physical configurations or individual patient source placement configurations and includes general-purpose applicators such as hollow needles, tubes or catheters, ovoids or tandems.

Contacts#

Phone, Email table
PhoneEmail
1-888-474-7839info-us@sirtex.com

Regulatory Flags#

DUNS number
127504939
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014612108SIR-Spheres® Microspheres Activity Calculator (SMAC)X-SMAC-012021-08-16
00850055697003LAVA-18, 2 mLSLLES1822023-10-23
00850055697010LAVA-34, 2 mLSLLES3422023-10-23
00850055697027LAVA-18, 6 mLSLLES1862023-10-23
00850055697034LAVA-34, 6 mLSLLES3462023-10-23
00850055697041LAVA Mixing Kit, 2 mLSLLESMK22023-10-23
00850055697058LAVA Mixing Kit, 6 mLSLLESMK62023-10-23
00850014612153SIR-Spheres Y-90 resin microspheresSIR-Y0032026-05-28
00850014612030SIR-Spheres Y-90 resin microspheresSIR-Y0012024-07-15
00850014612146SIR-Spheres Y-90 resin microspheresSIR-Y0022024-03-28
00850014612061SIR-Spheres V-VialSIR-V0012021-07-15
00850014612047SIR-Spheres Delivery ApparatusSIR-B0012021-07-14
00850014612054SIR-Spheres Delivery SetSIR-D0012021-07-14
00850014612078SIR-Spheres V-Vial HolderSIR-H0012021-07-14
00850014612085SIR-Spheres Syringe ShieldSIR-S0012021-07-09
00850014612009SIROS Delivery DomeSIR-10100SIR-101002021-01-05
00850014612016SIROS D-Vial Prep SetSIR-10200SIR-102002021-01-05
00850014612023SIROS Delivery SetSIR-10300SIR-103002021-01-05
M425SIRY0010SIR-Spheres microspheresSIR-Y0012014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B16556450328083126173Single Leader Catheter with LuerLiberty Medical , Inc.IWJ2026-08-18
B16556500328083126172Small Prostate TemplateLiberty Medical , Inc.IWJ2026-08-18
B16557060328083126147Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B1655765032802312606Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16558000328043026121Small Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-08-18
B16559100328083126175ButtonsLiberty Medical , Inc.IWJ2026-08-18
B16560390328023126165Single Leader Catheter with LuerLiberty Medical , Inc.IWJ2026-08-18
B16570160328083126144Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16570170328083126159Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16570170328083126174Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B1657017032808312646Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16570550328083126017Gynecological TemplateLiberty Medical , Inc.IWJ2026-08-18
B16570940328083126166AdapterLiberty Medical , Inc.IWJ2026-08-18
B16570940328083126177AdapterLiberty Medical , Inc.IWJ2026-08-18
00841365121593Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-08-03
00841365121609Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-08-03
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.IWJ2026-07-23
B16556052032806302620Large Prostate TemplateLiberty Medical , Inc.IWJ2026-07-08
B16556510328063026080Medium Prostate TemplateLiberty Medical , Inc.IWJ2026-07-08
B16556630328063026137Intrauterine TandemLiberty Medical , Inc.IWJ2026-07-08
B16557060328060026140Flexi-NeedleLiberty Medical , Inc.IWJ2026-07-08
B16558000327103126049Small Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-07-08
B16558010328043026108Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-07-08
B16558100328103126034Small Prostate Brachytherapy Kit-metal hubLiberty Medical , Inc.IWJ2026-07-08
B16559070328063026073ButtonsLiberty Medical , Inc.IWJ2026-07-08
B16559080328063026059ButtonsLiberty Medical , Inc.IWJ2026-07-08
B16559100328063026111ButtonsLiberty Medical , Inc.IWJ2026-07-08
B16570160328063026139Flexi-NeedleLiberty Medical , Inc.IWJ2026-07-08
B1657060328063026115Flexi-NeedleLiberty Medical , Inc.IWJ2026-07-08