FDA.reportPublic FDA data

PET VIAL SHIELD

Primary DI
00718175001820
Brand
PET VIAL SHIELD
Company
BIODEX MEDICAL SYSTEMS, INC.
Model
001-855
Catalog number
001-855
Device description
Vial Shield, Dose Drawing, PET, 30 ml
Published
2018-12-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00718175001820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175001820007181750018207181750018200718175001820

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043833813
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00718175003381SHARPS CONTAINER SHIELD 039-350039-3502019-05-31
00718175003657Neck Phantom 043-365043-3652018-02-15
00718175005002Xenon Rebreathing System 132-680132-6802019-09-30
00718175005019Xenon Rebreathing System 132-681132-6812019-10-16
00718175005040Xenon Rebreathing System 132-690132-6902019-10-16
00718175005057Xenon Rebreathing System 132-691132-6912019-10-16
00718175005064Xenon Rebreathing System 132-692132-6922019-10-16
00718175005071Xenon Rebreathing System 132-699132-6992019-10-16
00718175005088Xenon Rebreathing System 132-770132-7702019-10-16
00718175005101Xenon Rebreathing System 132-774132-7742019-10-17
00718175005125Xenon Rebreathing System 132-784132-7842019-10-16
00718175005132Xenon Rebreathing System 132-793132-7932019-10-16
00718175005149Xenon Rebreathing System 132-771132-7712019-10-16
00718175005156VENTI-SCAN IV177-075177-0752019-12-13
00718175005163AIR CUSHIONED FACE MASK132-685132-6852019-12-13
00718175005170AIR CUSHIONED FACE MASK132-695132-6952019-12-13
00718175005187AIR CUSHIONED FACE MASK132-698132-6982019-12-13
00718175005200BACTERIAL FILTER132-750132-7502019-12-13
00718175005248XENON CONVENIENCE KITS 134-772134-7722019-12-13
00718175002902LEAD LINED 244-157244-1572020-06-17

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 PTY LTDIWW2021-07-14
00850014612016SIROS D-Vial Prep SetSIRTEX MEDICAL PTY LTDIWW2021-01-05
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