FDA.reportPublic FDA data

EZCOVER® Gel-Free

Primary DI
05407006211327
Brand
EZCOVER® Gel-Free
Company
MedXPress.Pro
Model
PCAG15030-03
Device description
EZCOVER® Gel-Free 30 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
05407006211334PackageGS150In Commercial Distribution
05407006211341PackageGS1300In Commercial Distribution
05407006211327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05407006211334054070062113345407006211334
05407006211341054070062113415407006211341
05407006211327054070062113275407006211327

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
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
05407006211532EZCOVER® STOP Gel-VisionPCT15244-032025-03-26
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
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27