FDA.reportPublic FDA data

EZCOVER® Gel-Vision

Primary DI
05407006211211
Brand
EZCOVER® Gel-Vision
Company
MedXPress.Pro
Model
PCG15030-03
Device description
EZCOVER® Gel-Vision 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
OTC
false
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
05407006211211PackageGS130In Commercial Distribution
05407006211228PackageGS1180In Commercial Distribution
05407006211204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05407006211211054070062112115407006211211
05407006211228054070062112285407006211228
05407006211204054070062112045407006211204

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
371406782
Device count
1
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
true
Sterilization required before use
false

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
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
05407006211242EZCOVER® Gel-VisionPCG15061-032025-03-26
05407006211273EZCOVER® Gel-VisionPCG15122-032025-03-26
05407006211303EZCOVER® Gel-VisionPCG15244-032025-03-26
05407006211334EZCOVER® Gel-FreePCAG15030-032025-03-26

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Primary DI, Brand, Company table
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00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125833Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125857Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126045Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126656Multi-Purpose Workstation ™ StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126663CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
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00841517112028iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
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00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
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00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
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00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
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