FDA.reportPublic FDA data

DynaGel™ Ultrasound Gel, 5 Liters, Blue

Primary DI
10660584000222
Brand
DynaGel™ Ultrasound Gel, 5 Liters, Blue
Company
Dynatronics Corporation
Model
5LTRGEL-B
Catalog number
5LTRGEL-B
Published
2016-11-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K012522000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012522000WAVELENGTH MULTI-PURPOSE ULTRASOUND GELNational Therapy Products, Inc.2001-10-18ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10660584000222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1066058400022210660584000222

GMDN Terms#

Term, Definition table
TermDefinition
Topical 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Liter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113399125
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10660584000017Dynatron Solaris Plus 709D719T2016-09-24
10660584000024Dynatron Solaris Plus 708D718T2016-09-24
10660584000031Dynatron Solaris Plus 707D7172016-09-24
10660584000048Dynatron Solaris Plus 706D716T2016-09-24
10660584000055Dynatron Solaris Plus 705D715T2016-09-24
10660584000109Dynatron 25 Series 925BD925T2016-09-24
10660584000116Dynatron 25 Series 825BD825T2016-09-24
10660584000123Dynatron 25 Series 625BD625T2016-09-24
10660584000130Dynatron 25 Series 525BD525T2016-09-24
10660584000338Dynatron Solaris Plus 709D7192016-09-24
10660584000918DynaGel™ Ultrasound Gel, 5 Liters, Clear5LTRGEL5LTRGEL2016-11-18
10660584000895DynaGel™ Ultrasound Gel, sample7B02177B02172016-11-18
10660584000901DynaGel™ Ultrasound Gel, 5 Liters, Blue5LTRGEL-B2018-10-18
10660584000925Dynatron® Lotion, 1 GallonDL1DL12016-11-18
10660584000277Dynatron Soundhead WSH022016-09-24
10660584000284Dynatron SoundheadWSH052016-09-24
10660584000291Dynatron Soundhead `WSH102016-09-24
10660584000185Solaris Soundhead9GSH022016-09-24
10660584000192Solaris Soundhead9GSH052016-09-24
10660584000208Solaris Soundhead9GSH102016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436127028Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436127035Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125311CIV-Clear™ Transducer CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125915Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125939Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125953Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127056Cable SleeveCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127186Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGITX2026-07-24
04987670106088CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-07-24
00841436122061Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125444CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
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
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