FDA.reportPublic FDA data

Scrip Hessco

Primary DI
00812433023064
Brand
Scrip Hessco
Company
Scriphessco
Model
663 0004
Device description
Scrip Hessco Ultrasound Gel, 5L
Published
2017-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00812433023064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812433023064008124330230648124330230640812433023064

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6307717459lrogus@scripco.com

Regulatory Flags#

DUNS number
054152269
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812433025204Scrip Hessco663 00122017-06-05
00812433029295Scrip Hessco663 00192017-06-05
00812433023057Scrip Hessco232 01632017-07-17
00812433023071Scrip Hessco672 00102017-05-23
00812433023088Scrip Hessco672 00182017-05-23
00812433023095Scrip Hessco672 00232017-05-23
00812433023101Scrip Hessco672 00282017-05-23
00812433023118Scrip Hessco672 01922017-05-23
00812433023125Scrip Hessco672 01932017-05-23
00812433020001Scrip Hessco663 00612019-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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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
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
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