FDA.reportPublic FDA data

EZCOVER® STOP Gel-Vision

Primary DI
05407006211532
Brand
EZCOVER® STOP Gel-Vision
Company
MedXPress.Pro
Model
PCT15244-03
Device description
EZCOVER® STOP Gel-Vision 244 cm long
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
K191491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191491000EZ-CoverMedxpress.Pro2020-06-05ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05407006211549PackageGS125In Commercial Distribution
05407006211556PackageGS1150In Commercial Distribution
05407006211532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05407006211549054070062115495407006211549
05407006211556054070062115565407006211556
05407006211532054070062115325407006211532

GMDN Terms#

Term, Definition table
TermDefinition
Body-surface ultrasound imaging transducer coverA device/material 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 system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.

Regulatory Flags#

DUNS number
371406782
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05407006211204EZCOVER® Gel-VisionPCG15030-032025-03-26
05407006211235EZCOVER® Gel-VisionPCG15061-032025-03-26
05407006211266EZCOVER® Gel-VisionPCG15122-032025-03-26
05407006211297EZCOVER® Gel-VisionPCG15244-032025-03-26
05407006211327EZCOVER® Gel-FreePCAG15030-032025-03-26
05407006211358EZCOVER® Gel-FreePCAG15061-032025-03-26
05407006211389EZCOVER® Gel-FreePCAG15122-032025-03-26
05407006211419EZCOVER® Gel-FreePCAG15244-032025-03-26
05407006211440EZCOVER® STOP Gel-VisionPCT15030-032025-03-26
05407006211471EZCOVER® STOP Gel-VisionPCT15061-032025-03-26
05407006211501EZCOVER® STOP Gel-VisionPCT15122-032025-03-26
05407006211563EZCOVER® STOP Gel-FreePCAT15030-032025-03-26
05407006211594EZCOVER® STOP Gel-FreePCAT15061-032025-03-26
05407006211624EZCOVER® STOP Gel-Free PCAT15122-032025-03-26
05407006211655EZCOVER® STOP Gel-FreePCAT15244-032025-03-26
05407006211211EZCOVER® Gel-VisionPCG15030-032025-03-26
05407006211242EZCOVER® Gel-VisionPCG15061-032025-03-26
05407006211273EZCOVER® Gel-VisionPCG15122-032025-03-26
05407006211303EZCOVER® Gel-VisionPCG15244-032025-03-26
05407006211334EZCOVER® Gel-FreePCAG15030-032025-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08800290027266PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027419LA2-9SDSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290028638CA2-8ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029390EV2-10ASAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029420CV1-8AESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029512LA3-16ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029604L3-22SAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029611LA3-22AISAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029741EA2-11AVESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029789EA2-11ARESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.ITX2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08800289979132cV4 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07