FDA.reportPublic FDA data

SYRINGE SHIELD HOLDER

Primary DI
00718175009963
Brand
SYRINGE SHIELD HOLDER
Company
BIODEX MEDICAL SYSTEMS, INC.
Model
009-205
Catalog number
009-205
Device description
"HOLDER, SYRINGE SHIELD, .5"" THK LEAD"
Published
2019-09-16
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
IWRHolder, Syringe, Lead

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWRHolder, Syringe, LeadRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00718175009963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175009963007181750099637181750099630718175009963

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding container, general-purposeA radiation protection device intended for hospital or clinic use that is specifically designed to shield persons from unintended radiation exposure to radioactive materials, sources, devices, and/or radiopharmaceuticals that are being kept in the facility. The design typically incorporates lead shielding or plastic materials of sufficient thickness to attenuate a specified level of radioactivity. This GMDN code does not include special purpose containers designed as vial or syringe shields or transportation/transfer containers.

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
03701430100113Mediclic HELEMER PAXIWR2024-02-09
03701430100298Mediclic LELEMER PAXIWR2024-02-09
03701430100465Easyview LELEMER PAXIWR2024-02-09
03701430100496Easyview LELEMER PAXIWR2024-02-09
03701430100526Easyview LELEMER PAXIWR2024-02-09
03701430100601EASYSQUEEZELEMER PAXIWR2023-12-25
03701430100618EASYSQUEEZELEMER PAXIWR2023-12-25
00859942006492Pro-Tec II 3 cc with lead glass windowMirion Technologies (capintec), Inc.IWR2022-07-11
00859942006508Pro-Tec II 3 cc without glass windowMirion Technologies (capintec), Inc.IWR2022-07-11
00859942006515Pro-Tec II 5 cc with lead glass windowMirion Technologies (capintec), Inc.IWR2022-07-11
00859942006522Pro-Tec II 5 cc Mirion Technologies (capintec), Inc.IWR2022-07-11
00859942006539Pro-Tec III 1 cc, BD Luer LokMirion Technologies (capintec), Inc.IWR2022-07-11
00859942006546Pro-Tec III 1 ccMirion Technologies (capintec), Inc.IWR2022-07-11
00859942006553Pro-Tec III 3 cc Mirion Technologies (capintec), Inc.IWR2022-07-11
00859942006560Pro-Tec III 5 cc Mirion Technologies (capintec), Inc.IWR2022-07-11
00859942006577Pro-Tec III 10 cc Mirion Technologies (capintec), Inc.IWR2022-07-11
00859942006584Pro-Tec III 2.5 cc Mirion Technologies (capintec), Inc.IWR2022-07-11
00859942006591Pro-Tec IV 1 cc Mirion Technologies (capintec), Inc.IWR2022-07-11
00859942006607Pro-Tec IV 3 cc Mirion Technologies (capintec), Inc.IWR2022-07-11
00859942006614Pro-Tec IV 5 cc Mirion Technologies (capintec), Inc.IWR2022-07-11
00859942006621Pro-Tec IV 10 cc Mirion Technologies (capintec), Inc.IWR2022-07-11
00859942006638Beta Syringe Shield, 1 ccMirion Technologies (capintec), Inc.IWR2022-07-11
00859942006645Beta Syringe Shield, 10 ccMirion Technologies (capintec), Inc.IWR2022-07-11
00859942006652Beta Syringe Shield, 20 ccMirion Technologies (capintec), Inc.IWR2022-07-11
00859942006669"Syringe Carrier, Large 0.125"" lead"Mirion Technologies (capintec), Inc.IWR2022-07-11
00859942006676Dose Drawing Syringe Shield, 3 ccMirion Technologies (capintec), Inc.IWR2022-07-11
00859942006683Dose Drawing Syringe Shield, 5/6 ccMirion Technologies (capintec), Inc.IWR2022-07-11
00859942006690Dose Drawing Syringe Shield, 10/12 ccMirion Technologies (capintec), Inc.IWR2022-07-11
00859942006706Dose Drawing Syringe Shield, 3 cc, with Replaceable GlassMirion Technologies (capintec), Inc.IWR2022-07-11
00859942006713Dose Drawing Syringe Shield, 5/6 cc, with Replaceable GlassMirion Technologies (capintec), Inc.IWR2022-07-11