FDA.reportPublic FDA data

Visura TEECAD Carrier Control Unit

Primary DI
00860226002536
Brand
Visura TEECAD Carrier Control Unit
Company
VISURA TECHNOLOGIES, INC.
Model
VS-V2
Catalog number
VIS0101
Device description
Visura TEECAD Carrier Control Unit
Published
2022-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDSGastroscope And Accessories, Flexible/Rigid
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180911000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180911000Visura Technologies TEECAD SystemVisura Technologies, LLC2018-06-20FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860226002512PreviousGS10
00860226002536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860226002512008602260025128602260025120860226002512
00860226002536008602260025368602260025360860226002536

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging transducer positioning unitA unit used to position an ultrasound system imaging transducer that is inserted into the body through an endoscope. This device is an accessory to a diagnostic ultrasound imaging system and it transmits electrical signals that, after processing, will display the position of a the transducer on a monitor. This unit will assist the endoscopist in the placement of the working transducer (the probe) and to allow monitoring of the movement after placement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(651) 236-9226quality@visuratechnologies.com

Regulatory Flags#

DUNS number
117057841
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860226002505TEECADCR-P12019-07-06
00860226002512TEECADVS-V12019-07-06
00860226002529Visura TEECAD CarrierCR-P2VIS01002022-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SITX2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920066PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920271PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920325PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920660PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826921230PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921278PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921353PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921865PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921940PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921957PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926068PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926075PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926082PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25