FDA.reportPublic FDA data

X-Drape

Primary DI
00840348524383
Brand
X-Drape
Company
AADCO MEDICAL, INC.
Model
D-111
Catalog number
D-111
Device description
"X-DRAPE 12""x24"" 0.25mm Pb Equiv w/Cutout Sterile X-ray Shield 10/box "
Published
2022-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IWQCurtain, Protective, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWQCurtain, Protective, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840348524383PrimaryGS10
00840348525090Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348524383008403485243838403485243830840348524383
00840348525090008403485250908403485250900840348525090

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Regulatory Flags#

DUNS number
153603204
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840348507690AADCOPB-505PB-5052022-12-14
00840348526493AADCON-640N-6402022-12-16
00840348526509AADCON-640DN-640D2022-12-16
00840348507409AADCOPB-200PB-2002022-12-07
00840348507416AADCOPB-201PB-2012022-12-07
00840348507454AADCOPB-206PB-2062022-12-07
00840348507461AADCOPB-207PB-2072022-12-07
00840348524185AADCOP-302P-3022022-12-07
00840348524192AADCOP-303P-3032022-12-07
00840348524208AADCOP-305P-3052022-12-07
00840348506396AADCOP-610P-6102022-12-14
00840348506402AADCOP-610CSP-610CS2022-12-14
00840348506419AADCOP-611P-6112022-12-14
00840348506426AADCOP-611CSP-611CS2022-12-14
00840348507997AADCOPBS-025PBS-0252022-12-14
00840348506259AADCOP-306P-3062022-12-07
00840348506709AADCOPB-121PB-1212022-12-07
00840348506716AADCOPB-121CPB-121C2022-12-07
00840348506723AADCOPB-122PB-1222022-12-07
00840348506730AADCOPB-122CPB-122C2022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850061871169IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
00850061871176IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
00850061871183IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
00850061871190IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
00850061871206IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
00840348525564AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525571AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525588AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525595AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525601AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525618AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525625AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525670AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525687AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525717AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525724AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525731AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525748AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525755AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525786AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525793AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525809AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525816AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525823AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525830AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525847AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525854AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525861AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525878AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525885AADCOAADCO MEDICAL, INC.IWQ2022-12-19