FDA.reportPublic FDA data

SIROS Delivery Dome

Primary DI
00850014612009
Brand
SIROS Delivery Dome
Company
Sirtex Medical Inc.
Model
SIR-10100
Catalog number
SIR-10100
Device description
Delivery Dome for the administration of SIR-Spheres
Published
2021-01-05
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
KPYShield, Protective, Personnel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014612009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014612009008500146120098500146120090850014612009

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding container, general-purposeA radiation protection device intended for hospital or clinic use that is specifically designed to shield persons from unintended radiation exposure to radioactive materials, sources, devices, and/or radiopharmaceuticals that are being kept in the facility. The design typically incorporates lead shielding or plastic materials of sufficient thickness to attenuate a specified level of radioactivity. This GMDN code does not include special purpose containers designed as vial or syringe shields or transportation/transfer containers.

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
00850014612085SIR-Spheres Syringe ShieldSIR-S0012021-07-09
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
00850061871213IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871220IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871237IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871459IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
20748426261936Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
20748426261950Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261901Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261925Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
10748426143525Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
10748426143532Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143504Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143511Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143542Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143559Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
10748426143099Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143426Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143433Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143457Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143495Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143061Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143412Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143481Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426144280Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143078Medline-MicrotekMicrotek Medical LLCKPY2025-09-25
00748426143467DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-25
10748426143471DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
10748426144270DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00748426143443DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00816611026052Halyard Scatter Radiation ShieldsANGIOSYSTEMS, INCORPORATEDKPY2025-01-30
00816611026069Halyard Scatter Radiation ShieldsANGIOSYSTEMS, INCORPORATEDKPY2025-01-30