FDA.reportPublic FDA data

Sheathes

Primary DI
20842418103201
Brand
Sheathes
Company
SHEATHING TECHNOLOGIES, INC.
Model
5-485
Device description
Polyurethane, 5"W x 48"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
Rx
false
OTC
false
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
20842418103201PackageGS13In Commercial Distribution
10842418103204PrimaryGS10
00842418103207Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084241810320120842418103201
1084241810320410842418103204
00842418103207008424181032078424181032070842418103207

GMDN Terms#

Term, Definition table
TermDefinition
Topical coupling gel, sterileA sterile medium designed to be applied to a patient's skin surface to provide a coupling between an ultrasound transducer and the patient, allowing for the emission and reception of ultrasonic waves that pass through the skin during an ultrasound examination requiring sterile procedure. It is in the form of a non-sticky, drip resistant, fluid-like gel that has been thermally sterilized (contains no degradation products of radiation sterilization) that also assists the operator's ability to move the ultrasound transducer (probe) smoothly over the skin to better scan the site of interest. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806806220
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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10197106242605CARDINAL HEALTHCardinal Health 200, LLCOIP2023-05-18
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10197106280522CARDINAL HEALTHCardinal Health 200, LLCOIP2023-05-08
10197106260289CARDINAL HEALTHCardinal Health 200, LLCOIP2023-05-03
10197106266656CARDINAL HEALTHCardinal Health 200, LLCOIP2023-05-03
10197106230695CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-25
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
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