FDA.reportPublic FDA data

Marketlab, Inc

Primary DI
00817517026795
Brand
Marketlab, Inc
Company
MARKETLAB INC.
Model
108239
Device description
"Sterile Probe Cover, Gel and Bands, 5"" x 48"" with 3D End"
Published
2023-03-16
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817517026795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817517026795008175170267958175170267950817517026795

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
848917027
Device count
1
Premarket exempt
true
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
00817518026107MarketLab, Inc.108165-FSC-AEL2026-07-16
00817518026268MarketLab, Inc.1000442-FSC2026-07-16
00817518026275MarketLab, Inc.1000443-FSC2026-07-16
00817518024523MarketLab, Inc.1087812025-12-18
00817643023972Hopkins1380422024-02-02
00817517027938Marketlab-Clinton1387632024-02-02
00817517027945Marketlab-Clinton1387642024-02-02
00817517027952Marketlab-Clinton1387652024-02-02
00817517027969Marketlab-Clinton1387662024-02-02
00817517027976Marketlab-Clinton1387672024-02-02
00817517027983Marketlab-Clinton1387682024-02-02
00817517027990Marketlab-Clinton1387692024-02-02
00817517028003Marketlab-Clinton1387702024-02-02
00817517028072Marketlab-Clinton1387712024-02-02
00817517028089Marketlab-Clinton1387722024-02-02
00817517028096Marketlab-Clinton1387732024-02-02
00817517028102Marketlab-Clinton1387742024-02-02
00817517028119Marketlab-Clinton1387752024-02-02
00817517028126Marketlab-Clinton1387762024-02-02
00817517028133Marketlab-Clinton1387772024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112011iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.ITX2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.ITX2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
10841436122662Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2025-12-31
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07