FDA.reportPublic FDA data

Kiltex Corporation

Primary DI
00859297006000
Brand
Kiltex Corporation
Company
Kiltex Corporation
Model
2.0UltrasoundProbeCover(100)
Device description
A non-sterile sheath (2.0cm x 20cm) 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, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 100 per bag.
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961029000KILTEX PROBE COVERKiltex Corp.1996-07-25IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859297006000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859297006000008592970060008592970060000859297006000

GMDN Terms#

Term, Definition table
TermDefinition
Body-orifice ultrasound imaging transducer cover, basic, non-sterileA non-sterile 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
024475421
Device count
1
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859297006017Kiltex Corporation2.0UltrasoundProbeCover(500)2016-09-13
00859297006024Kiltex Corporation2.6UltrasoundProbeCover(100)2016-09-13
00859297006031Kiltex Corporation2.6UltrasoundProbeCover(500)2016-09-13
00859297006048Kiltex Corporation3.5UltrasoundProbeCover(100)2016-09-13
00859297006055Kiltex Corporation3.5UltrasoundProbeCover(144)2016-09-13
00859297006062Kiltex Corpoartion3.5UltrasoundProbeCover(500)2016-09-13
00859297006079Kiltex Corporation3.5UltrasoundProbeCover(720)2016-09-13

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