FDA.reportPublic FDA data

SIR-Spheres Syringe Shield

Primary DI
00850014612085
Brand
SIR-Spheres Syringe Shield
Company
Sirtex Medical Inc.
Model
SIR-S001
Device description
SIR-Spheres Syringe Shield
Published
2021-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00850014612085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014612085008500146120858500146120850850014612085

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.

Contacts#

Phone, Email table
PhoneEmail
1-888-474-7839info-us@sirtex.com

Regulatory Flags#

DUNS number
127504939
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
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055697003LAVA-18, 2 mLSLLES1822023-10-23
00850055697010LAVA-34, 2 mLSLLES3422023-10-23
00850055697027LAVA-18, 6 mLSLLES1862023-10-23
00850055697034LAVA-34, 6 mLSLLES3462023-10-23
00850055697041LAVA Mixing Kit, 2 mLSLLESMK22023-10-23
00850055697058LAVA Mixing Kit, 6 mLSLLESMK62023-10-23
00850014612153SIR-Spheres Y-90 resin microspheresSIR-Y0032026-05-28
00850014612030SIR-Spheres Y-90 resin microspheresSIR-Y0012024-07-15
00850014612146SIR-Spheres Y-90 resin microspheresSIR-Y0022024-03-28
00850014612108SIR-Spheres® Microspheres Activity Calculator (SMAC)X-SMAC-012021-08-16
00850014612061SIR-Spheres V-VialSIR-V0012021-07-15
00850014612047SIR-Spheres Delivery ApparatusSIR-B0012021-07-14
00850014612054SIR-Spheres Delivery SetSIR-D0012021-07-14
00850014612078SIR-Spheres V-Vial HolderSIR-H0012021-07-14
00850014612092SIR-Spheres Accessories PackSIR-K0022021-07-14
00850014612009SIROS Delivery DomeSIR-10100SIR-101002021-01-05
00850014612016SIROS D-Vial Prep SetSIR-10200SIR-102002021-01-05
00850014612023SIROS Delivery SetSIR-10300SIR-103002021-01-05
M425SIRY0010SIR-Spheres microspheresSIR-Y0012014-09-24

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