FDA.reportPublic FDA data

ClearWave

Primary DI
30856724004333
Brand
ClearWave
Company
NEXT MEDICAL PRODUCTS, LLC
Model
17000
Device description
Ultrasound Gel, Medium Viscosity
Published
2016-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30856724004333PrimaryGS10
10856724004339Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085672400433330856724004333
1085672400433910856724004339

GMDN Terms#

Term, Definition table
TermDefinition
Coupling gel, non-sterileA non-sterile medium designed to be applied to a patient's unbroken skin surface to provide a coupling between an analytical device (e.g., ultrasound transducer, optical glucose monitoring system) and the patient, allowing for the emission and reception of signals (e.g., ultrasound, light) that pass through the skin during an examination. It is in the form of a non-sticky, fluid-like gel that may also assists the operator's ability to move the analytical device smoothly over the skin to better analyse the site of interest. It may be used by a healthcare professional or layperson. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078566628
Device count
12
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30856724004364Clear Image Singles02-100-0302023-06-12
30856724004371Clear Image Singles Sterile04-048-3002023-06-12
30856724004418Clear Image Singles Sterile04-048D2023-06-12
30856724004425ClearWave1024122023-06-12
30856724004456LithoClear11-60122023-06-12
30856724004463LithoClear11-04242023-06-12
30856724004487NovaplusV02-8122023-06-12
30856724004494NovaplusV05-8122023-06-12
30856724004500NovaplusV02-400B-0302023-06-12
30856724004517NovaplusV06-400B-0302023-06-12
30856724004524NovaplusV02-400-0302023-06-12
30856724004531NovaplusV06-400-0302023-06-12
30856724004593Clear Image Singles Lite06-100-0302023-06-12
30856724004609chattanooga42482023-06-12
30856724004432Clear Image02-60122023-06-12
30856724004449Clear Image05-60122023-06-12
07350025911205Vitrolife142132020-10-05
10856724004179Clear Image02-1052016-10-24
10856724004186Clear Image05-1052016-10-24
30856724004012Clear Image02-9122016-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290031522HERA Z20e Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08800290041705miniER7SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041934LA2-9SSAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041941CMV1-10SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042184PA1-5ASAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042542EV2-12SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042603CV1-8ASAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042665CA3-10ASAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041699L3-22SAMSUNG MEDISON CO., LTD.IYO2025-10-13
08800290042122LA2-16SSAMSUNG MEDISON CO., LTD.IYO2025-10-13
08800290042788LA2-14ASAMSUNG MEDISON CO., LTD.IYO2025-10-13