FDA.reportPublic FDA data

Sonigel Ultrasound Gel Couplants

Primary DI
00816864020043
Brand
Sonigel Ultrasound Gel Couplants
Company
METTLER ELECTRONICS CORP.
Model
1851
Catalog number
1851
Device description
Sonigel (250ml bottle)
Published
2017-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
10816864020040PackageGS112In Commercial Distribution
00816864020043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081686402004010816864020040
00816864020043008168640200438168640200430816864020043

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, single-useAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No
Storage Environment Temperature41 Degrees Fahrenheit80 Degrees Fahrenheit

Regulatory Flags#

DUNS number
008513913
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816864020210Sonicator Plus 920ME 920ME 9202016-09-15
00816864020227Sonicator Plus 930, 2 channelME 930ME 9302016-09-15
00816864020234Sonicator Plus 940, 4 channelME 940ME 9402016-09-15
00816864020241Sonicator Plus 992, 2 channelME 992ME 9922016-09-15
00816864020258Sonicator Plus 994, 4 channelME 994ME 9942016-09-15
00816864021682accufitaccufit2026-04-22
00816864020609Ultrasound Applicator 7410741074102016-09-15
00816864020616Ultrasound Applicator 7413741374132016-09-15
00816864020623Ultrasound Applicator 7431743174312016-09-15
00816864020630Applicator 7513751375132016-09-15
00816864020647Applicator 9201920192012016-09-15
00816864020654Applicator 9202920292022016-09-15
00816864020661Applicator 9401940194012016-09-15
00816864020678Applicator 9402940294022016-09-15
00816864020708Applicator 7001700170012016-09-15
00816864020715Applicator 7005700570052016-09-15
00816864020722Applicator 7107710771072016-09-15
00816864020739Applicator 7305730573052016-09-15
00816864020746Applicator 7310731073102016-09-15
00816864020753Applicator 7331733173312016-09-15

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Primary DI, Brand, Company table
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04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
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