FDA.reportPublic FDA data

ZVEST

Primary DI
00840186695122
Brand
ZVEST
Company
BURLINGTON MEDICAL, LLC
Model
U8ZVEST*F
Device description
Tailored ZVEST: Vest with Zipper Closure .25mm Xenolite 800 NL Size Female, U8ZVEST*F
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
00840186695122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840186695122008401866951228401866951220840186695122

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
G031QRSO2XFNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSO2XFRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSO2XFRLL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSO2XFTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSO2XMNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSO2XMRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSO2XMRLL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSO2XMTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOLFRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOLMNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOLMRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOLMRLL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOLMTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOMFNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOMFTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOXLFNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOXLFRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOXLFRLL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOXLFTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOXLMNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOXLMTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
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