FDA.reportPublic FDA data

Sheathes

Primary DI
10842418103006
Brand
Sheathes
Company
SHEATHING TECHNOLOGIES, INC.
Model
5-305
Device description
"Polyurethane, 5""W x 30""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled"
Published
2018-07-31
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
20842418103003PackageGS13In Commercial Distribution
10842418103006PrimaryGS10
00842418103009Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084241810300320842418103003
1084241810300610842418103006
00842418103009008424181030098424181030090842418103009

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative ultrasound imaging transducer coverA sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used intraoperatively, e.g., on internal organs, during an ultrasound examination. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956527959CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-09
10198956525252CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-06
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10198956479449CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-05
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10198956484696CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-01
10197106094143CARDINAL HEALTHCardinal Health 200, LLCOIP2024-01-10
10197106207574CARDINAL HEALTHCardinal Health 200, LLCOIP2023-09-27
10195594704599CARDINAL HEALTHCardinal Health 200, LLCOIP2023-06-01
10197106227787CARDINAL HEALTHCardinal Health 200, LLCOIP2023-05-31
10195594763831CARDINAL HEALTHCardinal Health 200, LLCOIP2023-05-16
10197106230695CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-25
10197106226872CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-20
10197106211441CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-05
10197106213117CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-05
10197106207680CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-03
10197106184530CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-21
10197106102053CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-15
10197106107928CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-10
10197106050521CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-08
10197106148761CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-02
10197106098493CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-01
10197106165652CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-01
10197106145982CARDINAL HEALTHCardinal Health 200, LLCOIP2023-02-23
10197106061718CARDINAL HEALTHCardinal Health 200, LLCOIP2023-02-16
10197106089743CARDINAL HEALTHCardinal Health 200, LLCOIP2023-01-30