FDA.reportPublic FDA data

SIROS D-Vial Prep Set

Primary DI
00850014612016
Brand
SIROS D-Vial Prep Set
Company
Sirtex Medical Inc.
Model
SIR-10200
Catalog number
SIR-10200
Device description
Set for the preparation of SIR-Spheres
Published
2021-01-05
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
IWWShield, Vial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWWShield, VialRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014612016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014612016008500146120168500146120160850014612016

GMDN Terms#

Term, Definition table
TermDefinition
Vial radiation shieldA device, sometimes called a vial holder, designed to partially or completely surround a vial or a container of a solid or liquid radioactive material. It protects persons from unnecessary radiation exposure by partially or totally blocking the radiation emissions from a vial or similar container holding a radiopharmaceutical or other radioactive material used in diagnostic or therapeutic procedures. It is made of lead (Pb) or lead-equivalent materials, the shielding properties may vary depending on the isotopes they are intended to be used with. Some include an opening that allows needle access to the vial contents and some are either totally transparent or include a window.

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
false
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
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
00850014612108SIR-Spheres® Microspheres Activity Calculator (SMAC)X-SMAC-012021-08-16
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
00850014612092SIR-Spheres Accessories PackSIR-K0022021-07-14
00850014612085SIR-Spheres Syringe ShieldSIR-S0012021-07-09
00850014612009SIROS Delivery DomeSIR-10100SIR-101002021-01-05
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
10815112021365Vented Cap for Waste Bottle Bracco Diagnostics Inc.IWW2023-10-16
10815112021372Waste BottleBracco Diagnostics Inc.IWW2023-10-16
30815112021369Vented Cap for Waste Bottle BRACCO DIAGNOSTICS INCIWW2023-10-16
30815112021376Waste BottleBRACCO DIAGNOSTICS INCIWW2023-10-16
30815112021383Elution Test Vial ShieldBracco Diagnostics Inc.IWW2023-06-23
10815112020047Vented Cap for Waste Bottle Bracco Diagnostics Inc.IWW2023-03-22
10815112020054Waste BottleBracco Diagnostics Inc.IWW2023-03-22
30815112020041Vented Cap for Waste Bottle BRACCO DIAGNOSTICS INCIWW2023-03-22
30815112020058Waste BottleBRACCO DIAGNOSTICS INCIWW2023-03-22
30815112020072Elution Test Vial Bracco Diagnostics Inc.IWW2023-03-22
10815112020085Elution Test Vial ShieldBracco Diagnostics Inc.IWW2023-03-21
00879942070002High Density Lead Glass Vial ShieldMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070019PET Vial PigMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070026Vial Shield, LeadMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070033Dose Drawing Vial Shield, PET 30 mlMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070040Dose Drawing Vial Shield, PET 50 mlMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070064Vial Shield, Lead with Magnetic CapMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070071Vial Shield, Lead with Magnetic Cap and Glass WindowMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070088Tungsten Vial Shield with Magnetic CapMirion Technologies (capintec), Inc.IWW2022-07-11
00879942070095Tungsten Vial ShieldMirion Technologies (capintec), Inc.IWW2022-07-11
00850014612078SIR-Spheres V-Vial HolderSirtex Medical Inc.IWW2021-07-14
00718175008478VIAL SHIELDBIODEX MEDICAL SYSTEMS, INC.IWW2020-04-13
00718175008614VIAL SHIELDBIODEX MEDICAL SYSTEMS, INC.IWW2020-04-13
00718175008850VIAL SHIELDBIODEX MEDICAL SYSTEMS, INC.IWW2020-04-13
00718175009086VIAL SHIELDBIODEX MEDICAL SYSTEMS, INC.IWW2020-04-13
00859942006317Capintec 511 T-Vial ShieldMirion Technologies (capintec), Inc.IWW2019-07-01
00718175000809VIAL SHIELDBIODEX MEDICAL SYSTEMS, INC.IWW2019-04-12
00718175000755HIGH DENSITY LEAD GLASS VIAL SHIELDBIODEX MEDICAL SYSTEMS, INC.IWW2019-04-10
00718175001707PET VIAL PIGBIODEX MEDICAL SYSTEMS, INC.IWW2018-12-15
00718175001714INTEGOBIODEX MEDICAL SYSTEMS, INC.IWW2018-12-15