FDA.reportPublic FDA data

SecureShield© Multipurpose 12" x 17" Scatter Reducing Drape

Primary DI
00860004894629
Brand
SecureShield© Multipurpose 12" x 17" Scatter Reducing Drape
Company
Barrier Technologies, LLC
Model
SS-5100
Device description
Radiation protection scatter reducing drape
Published
2022-08-02
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

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
00860004894629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004894629008600048946298600048946290860004894629

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding table drapeA protective device intended to be placed on/draped over part of an operating table for a radiological examination during a surgical procedure (e.g. fluoroscopy using a C-arm) to shield attending healthcare personnel from unnecessary exposure to radiation. It commonly consists of a fluid-resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material which may in part be segmented into strips to allow passage of equipment under the table. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
621134084
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
00850035588895Barrier Wrap with Support Radiation Protection Apron - Pb Standard - XX-LargeBWSP-PbS-XXL2022-10-13
00850035588901Support Vest & Skirt Radiation Protection Apron - Pb Standard - SmallSPVS-PbS-SM2022-10-13
00850035588918Support Vest & Skirt Radiation Protection Apron - Pb Standard - MediumSPVS-PbS-MD2022-10-13
00850035588925Support Vest & Skirt Radiation Protection Apron - Pb Standard - LargeSPVS-PbS-LG2022-10-13
00850035588932Support Vest & Skirt Radiation Protection Apron - Pb Standard - X-LargeSPVS-PbS-XL2022-10-13
00850035588949Support Vest & Skirt Radiation Protection Apron - Pb Standard - XX-LargeSPVS-PbS-XXL2022-10-13
00850035588956Standard Vest & Skirt Radiation Protection Apron - Pb Standard - SmallSVS-PbS-SM2022-10-13
00850035588963Standard Vest & Skirt Radiation Protection Apron - Pb Standard - Medium SVS-PbS-MD2022-10-13
00850035588970Standard Vest & Skirt Radiation Protection Apron - Pb Standard - Large SVS-PbS-LG2022-10-13
00850035588987Standard Vest & Skirt Radiation Protection Apron - Pb Standard - X-LargeSVS-PbS-XL2022-10-13
00850035588994Standard Vest & Skirt Radiation Protection Apron - Pb Standard - XX-Large SVS-PbS-XXL2022-10-13
00850035588635 Standard Vest & Skirt Radiation Protection Apron - Pb Free - Small SVS-PbF-SM2022-10-12
00850035588642Standard Vest & Skirt Radiation Protection Apron - Pb Free - MediumSVS-PbF-MD2022-10-12
00850035588659 Standard Vest & Skirt Radiation Protection Apron - Pb Free - Large SVS-PbF-LG2022-10-12
00850035588666Standard Vest & Skirt Radiation Protection Apron - Pb Free - Made to Measure SVS-PbF-MTM2022-10-12
00850035588673Standard Vest & Skirt Radiation Protection Apron - Pb Free - X-Large SVS-PbF-XL2022-10-12
00850035588680Standard Vest & Skirt Radiation Protection Apron - Pb Free - XX-Large SVS-PbF-XXL2022-10-12
00850035588697Barrier Flex Radiation Protection Apron w/Magnaguard - Pb Free - SmallMGF-PbF-SM2022-10-12
00850035588703 Barrier Flex Radiation Protection Apron w/Magnaguard - Pb Free - MediumMGF-PbF-MD2022-10-12
00850035588710Barrier Flex Radiation Protection Apron w/Magnaguard - Pb Free - LargeMGF-PbF-LG2022-10-12

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Primary DI, Brand, Company table
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00850061871411IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-01-30
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05055449412407KenexKENEX (ELECTRO-MEDICAL) LIMITEDKPY2026-01-07
10748426143075Medline-MicrotekMicrotek Medical LLCKPY2025-09-25
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