FDA.reportPublic FDA data

F01

Primary DI
00197513010463
Brand
F01
Company
BURLINGTON MEDICAL, LLC
Model
0000
Published
2023-02-03
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
00197513010463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197513010463001975130104631975130104630197513010463

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
G242TB3L90Techno-AideTechno-Aide, Inc.EAJ2025-12-22
G242TB3R90Techno-AideTechno-Aide, Inc.EAJ2025-12-22
G242TB5L90Techno-AideTechno-Aide, Inc.EAJ2025-12-22
G242TB5R90Techno-AideTechno-Aide, Inc.EAJ2025-12-22
G242TC3L90Techno-AideTechno-Aide, Inc.EAJ2025-12-22
G242TC3R90Techno-AideTechno-Aide, Inc.EAJ2025-12-22
G242TC5L90Techno-AideTechno-Aide, Inc.EAJ2025-12-22
00840348529333ErgoLiteAADCO MEDICAL, INC.EAJ2025-02-05
G242J23L90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242J23R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242J25L90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242J25R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JL3L90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JL3R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JL5L90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JL5R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JM3L90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JM3R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JM5R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JP3L90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JX3R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JX5L90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JX5R90Techno-AideTechno-Aide, Inc.EAJ2024-11-14
G242JM5L90Techno-AideTechno-Aide, Inc.EAJ2024-11-13
G242JP3R90Techno-AideTechno-Aide, Inc.EAJ2024-11-13
G242JP5L90Techno-AideTechno-Aide, Inc.EAJ2024-11-13
G242JP5R90Techno-AideTechno-Aide, Inc.EAJ2024-11-13
G242JS3L90Techno-AideTechno-Aide, Inc.EAJ2024-11-13
G242JS3R90Techno-AideTechno-Aide, Inc.EAJ2024-11-13
G242JS5L90Techno-AideTechno-Aide, Inc.EAJ2024-11-13