FDA.reportPublic FDA data

SKIRT

Primary DI
00840331222890
Brand
SKIRT
Company
BURLINGTON MEDICAL, LLC
Model
SPRSKIRT-5XM
Device description
SPRSKIRT-5XM (SKIRT: Wrap Around SKIRT .35MM PRESTIGE, 5XM)
Published
2022-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840331222890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840331222890008403312228908403312228900840331222890

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083381202
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197513011903Thyroid Shield BATR5BATH2024-08-26
00197513011910Thyroid Shield BATR5BATB2024-08-26
00197513011934Thyroid Shield BATR8BATH2024-08-26
00197513011941Thyroid Shield BATR8BATB2024-08-26
00197513012597TABLEPADAM3085-Q1.5-DBCBVHLA2024-11-22
00197513012016TABLEPADAM3085-Q1.5-DBCBVHLA2024-10-21
00197513011958TABLEPADSK3100-Q1.5-DBCBVHLA2024-10-21
00197513011965TABLEPADSK3100-T2.5-DBCBVHLA2024-10-21
00197513011972TABLEPADSK3100-T3-DBCBVHLA2024-10-21
00197513011989TABLEPADAM3080-Q1.5-DBCBVHLA2024-10-21
00197513011996TABLEPADAM3080-T2.5-DBCBVHLA2024-10-21
00197513012009TABLEPADAM3080-T3-DBCBVHLA2024-10-21
00197513012023TABLEPADAM3085-T2.5-DBCBVHLA2024-10-21
00197513012030TABLEPADAM3085-T3-DBCBVHLA2024-10-21
00197513012047TABLEPADSH4900-Q1.5-DBCBVHLA2024-10-21
00197513012054TABLEPADSH4900-T2.5-DBCBVHLA2024-10-21
00197513012061TABLEPADSH4900-T3-DBCBVHLA2024-10-21
00197513012078TABLEPADSK3600-Q1.5-DBCBVHLA2024-10-21
00197513012085TABLEPADSK3600-T2.5-DBCBVHLA2024-10-21
00197513012092TABLEPADSK3600-T3-DBCBVHLA2024-10-21

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