FDA.reportPublic FDA data

GONAD SHIELD

Primary DI
00840186698413
Brand
GONAD SHIELD
Company
BURLINGTON MEDICAL, LLC
Model
GONADSHIELD-RLGS4-TRI-STRAP
Device description
GONAD SHIELD, .5MM LEAD, LARGE, TRIANGULAR, STRAP ATTACHMENT
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IWTShield, Gonadal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWTShield, GonadalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840186698413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840186698413008401866984138401866984130840186698413

GMDN Terms#

Term, Definition table
TermDefinition
Gonad radiation shieldA personal protective device intended to shield the gonads of an individual (i.e., a device operator, patient, or other attending person) from unnecessary exposure to radiation from diagnostic medical and dental procedures by providing an attenuating barrier to the radiation. It comes in various configurations: 1) anatomically designed to fit over the gonads; 2) placed directly on the body; or 3) attached to the wall or radiation delivery device on an articulating arm. Radiation protection male and female gonadal shields are typically made of lead (Pb) or lead-equivalent material.

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
G031806ARL0Gonad Shield - set of 3 - no closureShielding International Inc.IWT2023-10-12
G031806SQRRL0Gonad Shield w/ QR BuckleShielding International Inc.IWT2023-10-12
G031806SRL0Gonad ShieldShielding International Inc.IWT2023-10-12
G031806STRL0Gonad Shield w/ TiesShielding International Inc.IWT2023-10-12
G031806SVRL0Gonad Shield w/ Hook & LoopShielding International Inc.IWT2023-10-12
G031807SQRRL0Ova Shield w/ hook & loopShielding International Inc.IWT2023-10-12
G031807SRL0Ova Shield - no closureShielding International Inc.IWT2023-10-12
G031807STRL0Ova Shield - w/ TiesShielding International Inc.IWT2023-10-12
G031807SVRL0Ova Shield w/ hook & loopShielding International Inc.IWT2023-10-12
G031822BBVRL0Gonadal & Ovarian Belt SystemShielding International Inc.IWT2023-10-12
00840348529227RayshieldAADCO MEDICAL, INC.IWT2023-06-23
00840348529234RayshieldAADCO MEDICAL, INC.IWT2023-06-23
00840348529241RayshieldAADCO MEDICAL, INC.IWT2023-06-23
00840348529258RayshieldAADCO MEDICAL, INC.IWT2023-06-23
00840348529265RayshieldAADCO MEDICAL, INC.IWT2023-06-23
G242GL5L9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GL5N9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GL5R9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GM5L9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GM5N9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GM5R9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GS5L9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GS5N9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GS5R9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GL5L90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GL5N90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GL5R90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GM5L90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GM5N90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GM5R90Techno-AideTechno-Aide, Inc.IWT2023-02-10