FDA.reportPublic FDA data

Pro-Tec II 3 cc with lead glass window

Primary DI
00859942006492
Brand
Pro-Tec II 3 cc with lead glass window
Company
Mirion Technologies (capintec), Inc.
Model
007-800
Catalog number
007-800
Device description
Tungsten syringe shield
Published
2022-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00859942006492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859942006492008599420064928599420064920859942006492

GMDN Terms#

Term, Definition table
TermDefinition
Syringe radiation shieldA radiation protective device made to surround a syringe while radioactive material is drawn up into the syringe and during patient injection. It is intended to shield the user from unnecessary exposure to radiopharmaceuticals or other radioactive material used in diagnostic or therapeutic procedures. It is typically made of lead (Pb), lead with a leaded glass insert, or clear lead-equivalent plastic materials.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-825-9500flo-techsupport@mirion.com

Regulatory Flags#

DUNS number
047684501
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859942006287CII Transporter0670-00070670-00072019-07-01
00859942006294CII Transporter II0670-20260670-20262019-07-01
008599420063002 cc Pin-Tec Syringe Shield4300-00604300-00602019-07-01
00859942006126Capintec Syringe Shield1 cc Pin-Tec Syringe Shield4300-00342018-11-28
00859942006133Capintec Syringe Shield3 cc PIn-Tec Syringe Shield4300-00352018-11-28
00859942006140Capintec Syringe Shield5 cc Pin-Tec Syringe Shield4300-00362018-11-28
00859942006157Capintec Syringe Shield10 cc Pin-Tec Syringe Shield4300-00372018-11-28
00859942006164Capintec Syringe Shield1 cc C-Tec Syringe Shield4300-00302018-11-28
00859942006171Capintec Syringe Shield3 cc C-Tec Syringe Shield4300-00312018-11-28
00859942006188Capintec Syringe Shield5 cc C-Tec Syringe Shield4300-00322018-11-28
00859942006195Capintec Syringe Shield10 cc C-Tec Syringe Shield4300-00332018-11-28
00859942006201Capintec Syringe Shield511 C-Tec Syringe Shield, 5 cc0665-20202018-11-28
00859942006218Capintec Syringe Shield511 C-Tec Syringe Shield, 10 cc0665-20152018-11-28
00859942006225Capintec Syringe Shield511 C-Tec Syringe Shield, 20 cc0665-20212018-11-28
00859942006263Capintec T-Vial ShieldT-Vial Shield0665-00022018-11-28
00879942070750MRI Stretcher240-100240-1002023-07-31
00879942070767MRI Stretcher with Fowler Positioning240-110240-1102023-07-31
00879942070644Ultra Pro Ultrasound Table, 230V058-725058-7252023-07-21
00879942070613Sound Pro Combination Ultrasound Table, 115V058-710058-7102023-07-14
00879942070620Sound Pro Combination Ultrasound Table, 230V058-715058-7152023-07-14

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
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
00859942006720Dose Drawing Syringe Shield, 10/12 cc, with Replaceable GlassMirion Technologies (capintec), Inc.IWR2022-07-11