FDA.reportPublic FDA data

Wolf X-Ray

Primary DI
00843696143459
Brand
Wolf X-Ray
Company
Flow X Ray Corporation
Model
63013TC-TB-38
Device description
Coat Apron with Thyroid Collar, XX Large, No Lead, Shimmering Green
Published
2020-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IWOApron, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWOApron, ProtectiveRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843696143459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843696143459008436961434598436961434590843696143459

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
010016319
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843696114312COMPRESSION PADDLE141072022-12-22
00081204503900DV-58 ADULT ECONO PAK182042023-08-09
00812045030115DX-58 ADULT PAPER PAK180012023-08-09
00812045030634DX-42 BITE CHEX180602023-08-09
00812045030832DV-57 ADULT TWIN VALUE PAK18201E2023-08-09
00812045030849DV-53 CHILD TWIN PEDO PAK18236E2023-08-09
00812045030856DSS-54 D CHILD SINGLE FILM BUTTERFLY PACKET19235E2023-08-09
00812045030863DSS-57 D ADULT SINGLE FILM BUTTERFLY PACKET19601E2023-08-09
00812045030870" DUPLICATING FILM, 14 X 17"""311762023-08-09
00812045030887DV-58 ADULT VALUE PAK182002023-08-09
00812045030894DV-57 ADULT TWIN VALUE PAK182012023-08-09
00812045030917DV-54 CHILD ECONO PAK182062023-08-09
00812045030924FV-58 ADULT ECONO PAK182152023-08-09
00812045030931DV-54 CHILD PEDO PAK182352023-08-09
00812045030948DV-53 CHILD TWIN PEDO PAK182362023-08-09
00812045030955FV-58 ADULT VALUE PAK183102023-08-09
00812045030962FV-57 ADULT TWIN VALUE PAK184102023-08-09
00812045030979DV-58 ADULT FRESH PAK186002023-08-09
00812045030986DV-57 ADULT TWIN FRESH PAK186012023-08-09
00812045030993FV-58 ADULT FRESH PAK186202023-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G242TC3N90Techno-AideTechno-Aide, Inc.IWO2025-12-22
00817169029380Visionary By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCIWO2025-12-16
G309SG20Stevens-MoonStevens-Moon Sales Professionals LLCIWO2025-05-21
G242J23N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242J25N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JL3N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JL5N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JM3N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JX3N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JX5N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JM5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242JP3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242JP5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242JS3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242JS5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242K23N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242K25N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KL3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KL5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KM3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KM5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KP3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KP5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KS3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KS5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KX3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KX5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
00197513011897Thyroid Shield BATBURLINGTON MEDICAL, LLCIWO2024-08-26
00197513011903Thyroid Shield BATBURLINGTON MEDICAL, LLCIWO2024-08-26
00197513011910Thyroid Shield BATBURLINGTON MEDICAL, LLCIWO2024-08-26