FDA.report

Easyview LE

Primary DI
03701430100526
Brand
Easyview LE
Company
LEMER PAX
Model
3 mL
Published
2024-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IWRHolder, Syringe, Lead

Product Code Classifications

CodeDeviceSpecialtyClass
IWRHolder, Syringe, LeadRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03701430100526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03701430100526037014301005263701430100526

GMDN Terms

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

Regulatory Flags

DUNS number
282028430
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03701430101042Theranojet000519232025-02-04
03701430100113Mediclic HE5 mL2024-02-09
03701430100298Mediclic LE1 mL2024-02-09
03701430100465Easyview LE10ml2024-02-09
03701430100496Easyview LE5 mL2024-02-09
03701430100601EASYSQUEEZE5 mL2023-12-25
03701430100618EASYSQUEEZE3 mL2023-12-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
03701430100113Mediclic HELEMER PAXIWR2024-02-09
03701430100298Mediclic LELEMER PAXIWR2024-02-09
03701430100465Easyview LELEMER PAXIWR2024-02-09
03701430100496Easyview LELEMER PAXIWR2024-02-09
03701430100601EASYSQUEEZELEMER PAXIWR2023-12-25
03701430100618EASYSQUEEZELEMER PAXIWR2023-12-25
00859942006492Pro-Tec II 3 cc with lead glass windowCAPINTEC, INC.IWR2022-07-11
00859942006508Pro-Tec II 3 cc without glass windowCAPINTEC, INC.IWR2022-07-11
00859942006515Pro-Tec II 5 cc with lead glass windowCAPINTEC, INC.IWR2022-07-11
00859942006522Pro-Tec II 5 cc CAPINTEC, INC.IWR2022-07-11
00859942006539Pro-Tec III 1 cc, BD Luer LokCAPINTEC, INC.IWR2022-07-11
00859942006546Pro-Tec III 1 ccCAPINTEC, INC.IWR2022-07-11
00859942006553Pro-Tec III 3 cc CAPINTEC, INC.IWR2022-07-11
00859942006560Pro-Tec III 5 cc CAPINTEC, INC.IWR2022-07-11
00859942006577Pro-Tec III 10 cc CAPINTEC, INC.IWR2022-07-11
00859942006584Pro-Tec III 2.5 cc CAPINTEC, INC.IWR2022-07-11
00859942006591Pro-Tec IV 1 cc CAPINTEC, INC.IWR2022-07-11
00859942006607Pro-Tec IV 3 cc CAPINTEC, INC.IWR2022-07-11
00859942006614Pro-Tec IV 5 cc CAPINTEC, INC.IWR2022-07-11
00859942006621Pro-Tec IV 10 cc CAPINTEC, INC.IWR2022-07-11
00859942006638Beta Syringe Shield, 1 ccCAPINTEC, INC.IWR2022-07-11
00859942006645Beta Syringe Shield, 10 ccCAPINTEC, INC.IWR2022-07-11
00859942006652Beta Syringe Shield, 20 ccCAPINTEC, INC.IWR2022-07-11
00859942006669Syringe Carrier, Large 0.125" leadCAPINTEC, INC.IWR2022-07-11
00859942006676Dose Drawing Syringe Shield, 3 ccCAPINTEC, INC.IWR2022-07-11
00859942006683Dose Drawing Syringe Shield, 5/6 ccCAPINTEC, INC.IWR2022-07-11
00859942006690Dose Drawing Syringe Shield, 10/12 ccCAPINTEC, INC.IWR2022-07-11
00859942006706Dose Drawing Syringe Shield, 3 cc, with Replaceable GlassCAPINTEC, INC.IWR2022-07-11
00859942006713Dose Drawing Syringe Shield, 5/6 cc, with Replaceable GlassCAPINTEC, INC.IWR2022-07-11
00859942006720Dose Drawing Syringe Shield, 10/12 cc, with Replaceable GlassCAPINTEC, INC.IWR2022-07-11