FDA.reportPublic FDA data

Xenolite

Primary DI
00615375001332
Brand
Xenolite
Company
Kerr Corporation
Model
31369DX
Device description
LeadFree XRay Apron with Collar Lite Weight XRay Protection Apron
Published
2017-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWOApron, protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWOApron, ProtectiveRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615375001332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615375001332006153750013326153750013320615375001332

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding apronA full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not expose the garment to any temperatures above 120

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18005377123customercare@kavokerrgroup.com

Regulatory Flags#

DUNS number
199354556
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195062145582ZenFlex CM818-36022026-02-19
00195062145599ZenFlex CM818-36032026-02-19
00195062145605ZenFlex CM818-36042026-02-19
00195062145612ZenFlex CM818-36052026-02-19
00195062145629ZenFlex CM818-36062026-02-19
00195062145636ZenFlex CM818-36072026-02-19
00195062145643ZenFlex CM818-36082026-02-19
00195062145650ZenFlex CM818-36092026-02-19
00195062145667ZenFlex CM818-36102026-02-19
00195062145674ZenFlex CM818-36112026-02-19
00195062145681ZenFlex CM818-36122026-02-19
00195062145698ZenFlex CM818-36132026-02-19
00195062145704ZenFlex CM818-36142026-02-19
00195062145711ZenFlex CM818-36152026-02-19
00195062145728ZenFlex CM818-36162026-02-19
00195062145735ZenFlex CM818-36172026-02-19
00195062145742ZenFlex CM818-36182026-02-19
00195062145247ZenFlex CM818-36022026-02-19
00195062145254ZenFlex CM818-36032026-02-19
00195062145261ZenFlex CM818-36042026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G031QRSOMFRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOMMNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOMMRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOMMRLL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOMMTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOSFNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOSFRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOSFRLL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOSFTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOSMNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOSMTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-28
G031QRSOSMRLL0Quick Release Skirt OnlyShielding International Inc.IWO2026-04-22
G031SO2XFRL0SkirtShielding International Inc.IWO2026-04-22
G031SO2XFRLL0SkirtShielding International Inc.IWO2026-04-22
G031SO2XFTL0SkirtShielding International Inc.IWO2026-04-22
G031SO2XMNL0SkirtShielding International Inc.IWO2026-04-22
G031SO2XMRL0SkirtShielding International Inc.IWO2026-04-22
G031SO2XMRLL0SkirtShielding International Inc.IWO2026-04-22
G031SO2XMTL0SkirtShielding International Inc.IWO2026-04-22
G031SOLFNL0SkirtShielding International Inc.IWO2026-04-22
G031SOLFRL0SkirtShielding International Inc.IWO2026-04-22
G031SOLFRLL0SkirtShielding International Inc.IWO2026-04-22
G031SOLFTL0SkirtShielding International Inc.IWO2026-04-22
G031SOLMNL0SkirtShielding International Inc.IWO2026-04-22
G031SOLMRL0SkirtShielding International Inc.IWO2026-04-22
G031SOLMRLL0SkirtShielding International Inc.IWO2026-04-22
G031SOLMTL0SkirtShielding International Inc.IWO2026-04-22
G031SOMFNL0SkirtShielding International Inc.IWO2026-04-22
G031SOMFRL0SkirtShielding International Inc.IWO2026-04-22
G031SOMFRLL0SkirtShielding International Inc.IWO2026-04-22