FDA.reportPublic FDA data

ArtUs

Primary DI
04772057000291
Brand
ArtUs
Company
TELEMED UAB
Model
L18-7H30-A5
Device description
Ultrasound transducer, linear array.
Published
2023-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K211248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211248000ArtUsTelemed2022-02-11IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04772057000291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04772057000291047720570002914772057000291

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+37052106272support@pcultrasound.com

Regulatory Flags#

DUNS number
366590052
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04772057000635ArtUsC15-7N30-A42024-08-09
04772057000253ArtUsEXT-1H2023-01-20
04772057000260ArtUsC6-1H50-A52023-01-20
04772057000277ArtUsC5-2H60-A52023-01-20
04772057000284ArtUs L15-7H40-A52023-01-20
04772057000307ArtUsP5-1S15-A62023-01-20
04772057000420MicrUs MC4-2R20S-32023-01-20
04772057000437MicrUs MC10-5R10S-32023-01-20
04772057000550ArtUsL12-5N40-A42023-01-20
04772057000567ArtUsLF9-5N60-A32023-01-20
04772057000574ArtUsLF11-5H60-A32023-01-20
04772057000581MicrUs EXT-1H Rev.E2023-01-20
04772057000598ArtUsEXT-2H2023-01-20
04772057000338MicrUs ProL40S2021-04-22
04772057000345MicrUs ProL40N2021-04-22
04772057000352MicrUs ProC60S2021-04-22
04772057000109MicrUsEXT-1H2017-04-30
04772057000116MicrUsL15-6L25S-32017-05-02
04772057000123MicrUsL12-5L40S-32017-06-28
04772057000130MicrUsC5-2R60S-32017-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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