FDA.report

X-Drape

Primary DI
00840348524932
Brand
X-Drape
Company
AADCO MEDICAL, INC.
Model
D-100E
Catalog number
D-100E
Device description
X-DRAPE 12"X17" 0.25mm Lead Equiv Sterile X-ray Shield
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
IWQCurtain, Protective, Radiographic

Product Code Classifications

CodeDeviceSpecialtyClass
IWQCurtain, Protective, RadiographicRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840348524222PrimaryGS10
00840348524932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348524222008403485242228403485242220840348524222
00840348524932008403485249328403485249320840348524932

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
153603204
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00840348529302AADCOPS-405SPS-405S2024-10-21
00840348529296AADCOOSP-260NFOSP-260NF2024-10-15
00840348529289ComfortLiteLP-CL800XALP-CL800XA2024-09-09
00840348526233AADCON-101N-1012022-12-15
00840348525694AADCODB-1922CF100DB-1922CF1002022-12-19
00840348525700AADCODB-1922CF1KDB-1922CF1K2022-12-19
00840348525762AADCODB-2620NDB-2620N2022-12-19
00840348525779AADCODB-2820NDB-2820N2022-12-19
00840348526806MRI-SafeNF-500NF-5002022-12-19

Other Devices Sharing Product Codes

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
00840348525694AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525700AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525762AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525779AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348524925X-DrapeAADCO MEDICAL, INC.IWQ2022-12-07
07332339220853StilleStille ABIWQ2020-09-30
07332339220860StilleStille ABIWQ2020-09-30
07332339220877StilleStille ABIWQ2020-09-30
07332339220891StilleStille ABIWQ2020-09-30
07332339221713StilleStille ABIWQ2020-09-30
07332339221720StilleStille ABIWQ2020-09-30
00852814003865RADPADWORLDWIDE INNOVATIONS & TECHNOLOGIES, INC.IWQ2020-07-17
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10852814003619RADPADWORLDWIDE INNOVATIONS & TECHNOLOGIES, INC.IWQ2016-10-25
10852814003626RADPADWORLDWIDE INNOVATIONS & TECHNOLOGIES, INC.IWQ2016-10-25
10852814003633RADPADWORLDWIDE INNOVATIONS & TECHNOLOGIES, INC.IWQ2016-10-25