FDA.reportPublic FDA data

Mediclic LE

Primary DI
03701430100298
Brand
Mediclic LE
Company
LEMER PAX
Model
1 mL
Published
2024-02-09
Public version status
New
Distribution status
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
03701430100298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701430100298037014301002983701430100298

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

Regulatory Flags#

DUNS number
282028430
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701430101042Theranojet000519232025-02-04
03701430100113Mediclic HE5 mL2024-02-09
03701430100465Easyview LE10ml2024-02-09
03701430100496Easyview LE5 mL2024-02-09
03701430100526Easyview LE3 mL2024-02-09
03701430100601EASYSQUEEZE5 mL2023-12-25
03701430100618EASYSQUEEZE3 mL2023-12-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701430100113Mediclic HELEMER 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
00859942006720Dose Drawing Syringe Shield, 10/12 cc, with Replaceable GlassMirion Technologies (capintec), Inc.IWR2022-07-11