FDA.reportPublic FDA data

Elution Test Vial Shield

Primary DI
10815112020085
Brand
Elution Test Vial Shield
Company
Bracco Diagnostics Inc.
Model
001550
Device description
Elution Test Vial Shield for use with CardioGen-82 Infusion System
Published
2023-03-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
10815112020085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081511202008510815112020085

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

Contacts#

Phone, Email table
PhoneEmail
800-447-6883xx@xx.xx

Regulatory Flags#

DUNS number
849234661
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815112020214Fast Find Grid: Disposable CT Biopsy Grid6000016000012016-09-19
10815112021167Rounded Flexi Tip Adult Enema Tip9013019013012023-05-25
10815112021181Miller Enema Air Tip with Non-Latex Retention Cuff9012019012012023-05-25
10815112021198Miller Enema Air Tip with Retention Cuff9012029012022023-05-25
30815112021703Two Tank Shuttle Valve System7106027106022025-06-30
30815112021710DIN 477 High Pressure Hose for CO23905133905132025-06-30
30815112021291High Pressure Hose and Yoke7106037106032023-08-31
10815112021174Enema Kit: Empty Enema Bag Delivery System9003029003022023-05-25
1081511202120418 French Pediatric Flexi Tip9013089013082023-05-25
30815112020805High Pressure DISS Hose For CO27106047106042016-09-19
30815112020782Two Tank Shuttle Valve System7106027106022016-09-19
10815112020535E-Z-GEL UltraSound Gel6010016010012016-09-23
10815112020542E-Z-SCAN Low Viscosity UltraSound Gel6010026010022016-09-23
10815112020559E-Z-SCAN Low Viscosity UltraSound Gel6010036010032016-09-23
10815112020566E-Z-GEL UltraSound Gel6010046010042016-09-23
10815112021402E-Z-GEL UltraSound Gel6010016010012025-05-16
10815112021419E-Z-SCAN Low Viscosity UltraSound Gel6010026010022025-05-16
10815112021426E-Z-SCAN Low Viscosity UltraSound Gel6010036010032025-05-16
10815112021433E-Z-GEL UltraSound Gel6010046010042025-05-16
10815112020856"""Y"" Connector with Tubing"9004029004022016-09-19

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
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
00850014612016SIROS D-Vial Prep SetSirtex Medical Inc.IWW2021-01-05
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
00718175001714INTEGOBIODEX MEDICAL SYSTEMS, INC.IWW2018-12-15