FDA.reportPublic FDA data

Xguard

Primary DI
08054301890435
Brand
Xguard
Company
EMERSON & CO SRL
Model
SleeveS
Catalog number
SleeveS
Device description
Radiation Reducing Sleeves
Published
2018-03-16
Public version status
New
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
08054301891173PackageGS13In Commercial Distribution
08054301890435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054301891173080543018911738054301891173
08054301890435080543018904358054301890435

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00in a dry place away from light and heat sources (below 35°).

Regulatory Flags#

DUNS number
630558211
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054301890602FreeguardModel160Model1602018-03-16
08054301890619FreeguardModel165Model1652018-03-16
08054301890626FreeguardModel170Model1702018-03-16
08054301890633FreeguardModel175Model1752018-03-16
08054301890640FreeguardModel180Model1802018-03-16
08054301890657FreeguardModel185Model1852018-03-16
08054301890664FreeguardModel190Model1902018-03-16
08054301890671FreeguardModel260Model2602018-03-16
08054301890688FreeguardModel265Model2652018-03-16
08054301890695FreeguardModel270Model2702018-03-16
08054301890701FreeguardModel275Model2752018-03-16
08054301890718FreeguardModel280Model2802018-03-16
08054301890725FreeguardModel285Model2852018-03-16
08054301890732FreeguardModel290Model2902018-03-16
08054301891500FreeguardModel170Model1702021-01-26
08054301891517FreeguardModel175Model1752021-01-26
08054301891531FreeguardModel185Model1852021-01-28
08054301891548FreeguardModel190Model1902021-01-28
08054301891555FreeguardModel260Model2602021-01-28
08054301891562FreeguardModel265Model2652021-01-28

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