FDA.reportPublic FDA data

AccuGel

Primary DI
20851491007368
Brand
AccuGel
Company
Lynn Medical Instrument Co.
Model
AG-08
Catalog number
AG-08
Device description
ACCUGEL ULTRASOUND GEL .025 LITER DISPENSER
Published
2017-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10851491007361PackageGS112In Commercial Distribution
20851491007368PackageGS148In Commercial Distribution
00851491007364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085149100736110851491007361
2085149100736820851491007368
00851491007364008514910073648514910073640851491007364

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 Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1888-596-6633customerservice@lynnmed.com

Regulatory Flags#

DUNS number
058810771
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851491007555AccuSensorST-50ST-502026-07-28
00851491007562AccuSensorST-50ST-502026-07-24
00851491007142Lynn Medical - Ambulatory Kit3111163111162018-10-08
00851491007487Direct IV Solutions - IV Start Kit2533-20G2533-20G2020-04-23
00851491007500Direct IV Solutions - IV Start Kit2534-20G2534-20G2020-04-23
00851491007517Direct IV Solutions - IV Start Kit2533-22G2533-22G2020-04-23
00851491007524Direct IV Solutions - IV Start Kit2534-22G2534-22G2020-04-23
00851491007012AccuSensor930-100930-1002016-12-09
00851491007029AccuSensor950-100950-1002016-12-09
00851491007036AccuSensor990-100990-1002016-12-09
00851491007043AccuSensor550-048550-0482016-12-09
00851491007128AccuSensor310-050TS310-050TS2016-12-09
00851491007135AccuSensorLM33-1-30LM33-1-302016-12-09
00851491007159AccuSensor630-005630-0052016-12-09
00851491007166AccuSensor630-030630-0302016-12-09
00851491007173AccuSensor690-005690-0052016-12-09
00851491007548AccuSensor910-100910-1002020-06-25
00851491007074AccuSensor510-005510-0052016-12-09
00851491007111AccuSensorST-50ST-502016-12-09
00851491007333AccuGelAG-50CL-HVAG-50CL-HV2017-02-13

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