FDA.reportPublic FDA data

Marketlab, Inc

Primary DI
00817517026788
Brand
Marketlab, Inc
Company
MARKETLAB INC.
Model
108238
Device description
"Sterile Probe Cover, PE, Gel and Bands, 5"" x 48"""
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
00817517026788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817517026788008175170267888175170267880817517026788

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
06948941160022Bladder ScannerMeda Co., LtdITX2026-10-08
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04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayQISDA CORPORATIONITX2026-10-01
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.ITX2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationITX2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SITX2026-09-21
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00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
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