FDA.reportPublic FDA data

Wavelength

Primary DI
00628108100196
Brand
Wavelength
Company
National Therapy Products Inc
Model
NTPC202T
Device description
Wavelength Ultrasound Gel Clear 250mL
Published
2018-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
MUIMedia, Coupling, Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
MUIMedia, Coupling, UltrasoundRadiology2

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
10628108100193PackageGS124In Commercial Distribution
00628108100196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062810810019310628108100193
00628108100196006281081001966281081001960628108100196

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

Regulatory Flags#

DUNS number
200149883
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628108100257WavelengthNTPA102X2019-06-04
00628108100264WavelengthNTPB100X2019-06-04
00628108100288WavelengthNTPC204X2019-06-04
00628108100301WavelengthNTPD373C2019-06-04
00628108100318WavelengthNTPF100X2019-06-04
00628108100325WavelengthNTPF101X2019-06-04
00628108100332Wavelength NTPF301X2019-06-04
00628108100349WavelengthNTPF202T2019-06-04
00628108100394WavelengthNTPA480X2023-11-27
00628108100400WavelengthNTPC480X2023-11-27
00628108100356SonicshieldSONX201X2021-08-17
00628108100363SonicshieldSONX020X2021-08-17
00628108100370SonicshieldSONX500X2021-08-17
00628108100271WavelengthNTPC025X2019-06-04
00628108100011WavelengthNTPC201W2016-11-16
00628108100028WavelengthNTPB201X2016-11-16
00628108100035WavelengthNTPF201X2016-11-16
00628108100042WavelengthNTPA201W2016-11-16
00628108100059WavelengthNTPE201X2016-11-16
00628108100066WavelengthNTPD201X2016-11-16

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Primary DI, Brand, Company table
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04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX 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
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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
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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