FDA.reportPublic FDA data

PRO-TEC PIG

Primary DI
00718175000830
Brand
PRO-TEC PIG
Company
BIODEX MEDICAL SYSTEMS, INC.
Model
001-282
Catalog number
001-282
Device description
Pig, Pro-Tech, 3/6cc Blue
Published
2019-04-12
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
10718175000837PackageGS16In Commercial Distribution
00718175000830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1071817500083710718175000837
00718175000830007181750008307181750008300718175000830

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding container, transport/transferA radiation protection device specifically designed to shield persons from harmful radiation exposure during air or land based shipping, transfer and delivery of radioactive materials (e.g., radioisotopes) from facility to facility. Designs typically incorporate a container with a lead lining sufficient to attenuate the emissions from the contained radioactive materials, sources, radiopharmaceuticals, or radiation containing devices being transported. This device is used for intra- and inter-hospital transportation of syringes, vials or other devices containing radioisotopes.

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