FDA.reportPublic FDA data

VEST

Primary DI
00840186668898
Brand
VEST
Company
BURLINGTON MEDICAL, LLC
Model
SLVEST-LF
Device description
Custom VEST: Wrap Around Vest .35mm Regular Lead Size Female Large, SLVEST-LF
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
EAJApron, Leaded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAJApron, LeadedRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840186668898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840186668898008401866688988401866688980840186668898

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
G031VBO2XFNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XFRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XFRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XFTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XFTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMNLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFNLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMNLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFNLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMMNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13