FDA.reportPublic FDA data

CAP

Primary DI
00840331243611
Brand
CAP
Company
BURLINGTON MEDICAL, LLC
Model
CAPE-RECAP-SM_MD
Device description
Cap - Standard Size with Drawstring Toggle Closure, .5mm Envirolite Size Small / Medium
Published
2022-09-16
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
00840331243611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840331243611008403312436118403312436110840331243611

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.

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
G031VBO2XFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13