FDA.reportPublic FDA data

Clear Image

Primary DI
30856724004029
Brand
Clear Image
Company
NEXT MEDICAL PRODUCTS, LLC
Model
02-405
Device description
Clear Image Ultrasound Gel, High Viscosity, 5L
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
30856724004029PrimaryGS10
10856724004025Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085672400402930856724004029
1085672400402510856724004025

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
4
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
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
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYO2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.IYO2026-08-07
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYO2026-07-24
00841436122672Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
00198953113493LOGIQGE Ultrasound Korea Ltd.IYO2026-01-21
00841436126311Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00198953042731LOGIQGE Ultrasound Korea Ltd.IYO2025-12-05
00198953042748LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05