FDA.reportPublic FDA data

Visura TEECAD Carrier

Primary DI
00860226002529
Brand
Visura TEECAD Carrier
Company
VISURA TECHNOLOGIES, INC.
Model
CR-P2
Catalog number
VIS0100
Device description
Visura TEECAD Carrier
Published
2022-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
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
00860226002505PreviousGS10
00860226002529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860226002505008602260025058602260025050860226002505
00860226002529008602260025298602260025290860226002529

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
Lot or batch
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
00860226002536Visura TEECAD Carrier Control UnitVS-V2VIS01012022-07-26

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
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04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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04580826926075PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926082PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25