FDA.reportPublic FDA data

AngioSystems SorbX

Primary DI
00816611021996
Brand
AngioSystems SorbX
Company
ANGIOSYSTEMS, INCORPORATED
Model
SX7100
Published
2018-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
00816611022009PackageGS115In Commercial Distribution
00816611021996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816611022009008166110220098166110220090816611022009
00816611021996008166110219968166110219960816611021996

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding material, ionizingA radiation protection device that attenuates ionizing radiation used to create barriers between an individual or a specific body part and a source of primary or scattered radiation used in medical or dental procedures. This group of devices includes a variety of materials, e.g., lead (Pb) bricks and sheets, lead-equivalent materials, leaded glass or plastic, tungsten (W), low molecular weight plastics or hydrogenous materials. Examples of use can be: lead bricks to build protective structures, lead sheets used in walls and doors, leaded glass or leaded-plastic sheets used in windows, mouldable lead-equivalent plastic or thermoplastic materials used to shield specific anatomical areas.

Regulatory Flags#

DUNS number
144884467
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816611026557AngioSystems TrayKM5024-82025-06-25
00816611026564AngioSystems TrayKM5024-82025-06-25
00816611026533AngioSystems Tray702770272025-05-09
00816611026540AngioSystems Tray702770272025-05-09
00816611026519AngioSystems Tray70212025-04-14
00816611026526AngioSystems Tray70212025-04-14
00816611026496AngioSystems Drape3605-023605-022025-04-02
00816611026502AngioSystems Drape3605-023605-022025-04-02
00816611026472AngioSystems Drape3270NS2025-02-07
00816611026489AngioSystems Drape3270 2025-02-07
10816611026479AngioSystems Drape3270NS2025-02-07
10816611026486AngioSystems Drape3270 2025-02-07
00816611026007AngioSystems Tray5743-52025-01-31
00816611026021AngioSystems Tray5744-52025-01-31
00816611026366AngioSystems Tray7020-32025-01-31
00816611026373AngioSystems Tray5621-82025-01-31
00816611026380AngioSystems TrayKM5061-12025-01-31
00816611026397AngioSystems TrayKM5032-52025-01-31
00816611026410AngioSystems Tray5734-12025-01-31
00816611026427AngioSystems Drape3432-022025-01-31

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