FDA.reportPublic FDA data

CAP

Primary DI
00840186696457
Brand
CAP
Company
BURLINGTON MEDICAL, LLC
Model
CAP8-U8CAP-LG_XL
Device description
Cap - Standard Size with Drawstring Toggle Closure, .25mm Xneolite 800 NL Size Small / Medium, CAP8-U8CAP-LG_XL
Published
2022-09-09
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
00840186696457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840186696457008401866964578401866964570840186696457

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding head wearA personal protective device intended to shield the head of an individual (i.e., the operator or other attending person) from unnecessary primary and scattered radiation during diagnostic or therapeutic medical procedures. It can be shaped like a cap or hood and will typically consist of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Head wear used for neutron attenuation is composed of hydrogenous materials instead of lead; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials.

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