FDA.reportPublic FDA data

EURO

Primary DI
00840186672505
Brand
EURO
Company
BURLINGTON MEDICAL, LLC
Model
RLEUROXSM
Device description
WRAPCL-RLEURO-XSM (CUSTOM: EURO, .5MM LEAD, XSM)
Published
2021-09-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00840186672505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840186672505008401866725058401866725050840186672505

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083381202
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197513012597TABLEPADAM3085-Q1.5-DBCBVHLA2024-11-22
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
00197513012016TABLEPADAM3085-T1.5-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
00197513012108TABLEPADSK6700-Q1.5-DBCBVHLA2024-10-21
00197513012115TABLEPADSK6700-T2.5-DBCBVHLA2024-10-21
00197513012122TABLEPADSK6700-T3-DBCBVHLA2024-10-21
00197513012139TABLEPADSK6701-Q1.5-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