FDA.reportPublic FDA data

Techno-Aide

Primary DI
G242GM5L90
Brand
Techno-Aide
Company
Techno-Aide, Inc.
Model
GM-5L
Catalog number
GM-5L
Device description
Gonadal Guards MEDIUM - 0.50mm Lead Equivalence-LIGHTWEIGHT LEADED PROTECTIVE MEDIA
Published
2023-02-10
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

Contact Domains#

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
G242GM5L90PackageHIBCC1In Commercial Distribution
G242GM5L9PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+1(615)350-7030Customerservice@Techno-Aide.com

Regulatory Flags#

DUNS number
843929279
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
G242TB3L90Techno-AideTB-3LTB-3L2025-12-22
G242TB3R90Techno-AideTB-3RTB-3R2025-12-22
G242TB5L90Techno-AideTB-5LTB-5L2025-12-22
G242TB5R90Techno-AideTB-5RTB-5R2025-12-22
G242TC3L90Techno-AideTC-3LTC-3L2025-12-22
G242TC3N90Techno-AideTC-3NTC-3N2025-12-22
G242TC3R90Techno-AideTC-3RTC-3R2025-12-22
G242TC5L90Techno-AideTC-5LTC-5L2025-12-22
G242YCBJMR90Techno-AideYCBJ-MRYCBJ-MR2025-09-12
G242YVFUMR90Techno-AideYVFU-MRYVFU-MR2025-09-12
G242SB03RDBKMR90Techno-AideSB-03R-DBK-MRSB-03R-DBK-MR2025-09-09
G242SB07SDBKMR90Techno-AideSB-07S-DBK-MRSB-07S-DBK-MR2025-09-09
G242SB12RDBKMR90Techno-AideSB-12R-DBK-MRSB-12R-DBK-MR2025-09-09
G242SS03DBKMR90Techno-AideSS-03-DBK-MRSS-03-DBK-MR2025-09-09
G242YCADMR90Techno-AideYCAD-MRYCAD-MR2025-09-09
G242YCAKMR90Techno-AideYCAK-MRYCAK-MR2025-09-09
G242YCASMR90Techno-AideYCAS-MRYCAS-MR2025-09-09
G242YCBHMR90Techno-AideYCBH-MRYCBH-MR2025-09-09
G242YCBOMR90Techno-AideYCBO-MRYCBO-MR2025-09-09
G242YCDAMR90Techno-AideYCDA-MRYCDA-MR2025-09-09

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
G242GL5L90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GL5N90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GL5R90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GM5N90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GM5R90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GS5L90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GS5N90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GS5R90Techno-AideTechno-Aide, Inc.IWT2023-02-10
00840331274059GONADSHIELDBURLINGTON MEDICAL, LLCIWT2022-09-29
00840331274103GONADSHIELDBURLINGTON MEDICAL, LLCIWT2022-09-29
00840331274400GONADSHIELDBURLINGTON MEDICAL, LLCIWT2022-09-29
00840331274417GONADSHIELDBURLINGTON MEDICAL, LLCIWT2022-09-29
00840186698260GONAD SHIELDBURLINGTON MEDICAL, LLCIWT2022-09-23
00840186698277GONAD SHIELDBURLINGTON MEDICAL, LLCIWT2022-09-23
00840186698284GONAD SHIELDBURLINGTON MEDICAL, LLCIWT2022-09-23