FDA.reportPublic FDA data

Sheathes3D

Primary DI
10842418102801
Brand
Sheathes3D
Company
SHEATHING TECHNOLOGIES, INC.
Model
5-1245
Device description
"Seamless Viral Barrier Box End, Polyurethane, 1"" x 2.9"" Face to 4.5""W x 12""L, Sterile, Specialty Ultrasound Probe Cover with 20ml Sterile Gel & 2 Elastics, Rolled"
Published
2018-07-27
Public version status
Update
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
OIPRadiology-Diagnostic Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIPRadiology-Diagnostic KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20842418102808PackageGS13In Commercial Distribution
10842418102801PrimaryGS10
00842418102804Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084241810280820842418102808
1084241810280110842418102801
00842418102804008424181028048424181028040842418102804

GMDN Terms#

Term, Definition table
TermDefinition
Body-orifice ultrasound imaging transducer cover, basicA sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device.

Regulatory Flags#

DUNS number
806806220
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10842418101613Sheathes50040-2442016-09-23
10842418101620Sheathes50040-2452016-09-23
10842418101637Sheathes50040-2462016-09-23
10842418101644Sheathes50040-254842016-09-23
10842418101651Sheathes50040-263642016-09-23
10842418101668Sheathes50040-264842016-09-23
10842418101675Sheathes50040-269642016-09-23
10842418101682Sheathes50040-3012016-09-23
10842418101699Sheathes50040-3032016-09-23
10842418101705Sheathes50040-30352016-09-23
10842418101712Sheathes50040-3042016-09-23
10842418101729Sheathes50040-3052016-09-23
10842418101736Sheathes50040-30552016-09-23
10842418101743Sheathes50040-3062016-09-23
10842418101750Sheathes50040-3632016-09-23
10842418101767Sheathes50040-36352016-09-23
10842418101774Sheathes50040-3642016-09-23
10842418101798Sheathes50040-3652016-09-23
10842418101804Sheathes50040-3662016-09-23
10842418101811Sheathes50040-4842016-09-22

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Primary DI, Brand, Company table
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10197106252574CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-25
10197106226872CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-20
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10197106213117CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-05
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10197106098493CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-01
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10197106061718CARDINAL HEALTHCardinal Health 200, LLCOIP2023-02-16
10197106089743CARDINAL HEALTHCardinal Health 200, LLCOIP2023-01-30