FDA.reportPublic FDA data

Sheathes3D

Primary DI
20842418102402
Brand
Sheathes3D
Company
SHEATHING TECHNOLOGIES, INC.
Model
50001-IH366
Device description
Seamless Viral Barrier Contour Curved End, Latex-Free, 1"x 3" Face to 6"W x 36"L, Non-Sterile, Extended Field Ultrasound Probe & Cord Cover, Rolled
Published
2018-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153212000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153212000Sheathes Ultrasound Probe CoversSheathing Technologies, Inc.2016-03-04ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20842418102402PackageGS13In Commercial Distribution
10842418102405PrimaryGS10
00842418102408Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084241810240220842418102402
1084241810240510842418102405
00842418102408008424181024088424181024080842418102408

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806806220
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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

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00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
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