FDA.reportPublic FDA data

IR Shield

Primary DI
09421902825880
Brand
IR Shield
Company
ADEPT MEDICAL LIMITED
Model
AM0500
Catalog number
AM0500
Device description
Scatter Radiation Protection Shield
Published
2017-11-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IWXBarrier, Control Panel, X-Ray, Movable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWXBarrier, Control Panel, X-Ray, MovableRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421902825880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421902825880094219028258809421902825880

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding panel, portable/mobileA portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
592534619
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421901970345NeoZolineNZ3306NZ33062016-02-25
09421901970352NeoZolineNZ3306-2NZ3306-22016-02-25
09421901970369NeoZolineNZ3309NZ33092016-02-25
09421901970376NeoZolineNZ3309-2NZ3309-22016-02-25
09421901970383NeoZolineNZ3312NZ33122016-02-25
09421901970390NeoZolineNZ3312-2NZ3312-22016-02-25
09421901970406NeoZolineNZ3321NZ33212016-02-25
09421901970413NeoZolineNZ3321-2NZ3321-22016-02-25
09421905187770Adept Medical Retrograde IR Platform - Narrow + ExtensionAM0460AM04602026-02-09
09421905187787Adept Medical IR Platform Extension - NarrowAM0470AM04702026-02-09
09421902825927Arm StrapsAM0620AM06202018-05-24
09421902825491Adept Medical Femoral TableAM0300AM03002017-05-29
09421902825941Adept Medical Drape SupportAM1000AM10002018-07-25
09421905187374Adept Medical ArmSureAM0640AM06402024-03-20
09421905187435Adept Medical STARTableDAM0140D2024-02-15
09421905187558Adept Medical Arm Support PadAAM01712022-10-13
09421905187589Adept Medical Drape SupportBAM1000B2022-10-13
09421902825712Adept Medical STARTableAM0140CAM0140C2017-05-29
09421902825934Arm Sure ShieldAM0630AM06302018-05-24
09421902825347STARSupportAM0130AM01302018-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814907020548ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-14
00814907020340ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020562ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020579ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020593ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020609ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020623ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020647ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020654ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020661ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020425ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020432ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020463ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020500ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020555ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00811870037788Manus Medical, LLCManus Medical, LLCIWX2023-11-08
G242LPSGS24249Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSGS24369Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSGS24489Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSH36369Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSH48489Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSS24249Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSS24369Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSS24489Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST2424S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST2430S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST2436S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST2448S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST3030S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST3036S9Techno-AideTechno-Aide, Inc.IWX2023-10-20