FDA.reportPublic FDA data

MEDISONO

Primary DI
B369MES01030
Brand
MEDISONO
Company
Medisono, LLC
Model
Medisono END-VYS EC-550L/T Colonoscope
Catalog number
MES01030
Device description
Medisono END-VYS EC-550L/T Colonoscope
Published
2023-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDFColonoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211882000HD-550 Video Endoscope SystemSonoscape Medical Corp.2022-04-01NWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B369MES01030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic colonoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
13054063931nicolo.briante@strenamedical.com

Regulatory Flags#

DUNS number
079686615
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B369MUS05001MedisonoCONVEX ARRAY PROBE MODEL PB-C361-2 FOR MEDISONO P3MUS050012020-12-28
B369MUS05002MedisonoLINEAR ARRAY PROBE MODEL PB-L761-2 FOR MEDISONO P3MUS050022020-12-28
B369MUS05003MedisonoLINEAR ARRAY PROBE MODEL PB-L743-2 FOR MEDISONO P3MUS050032020-12-28
B369MUS05004MedisonoMICRO-CONVEX PROBE MODEL PB-C611-2 FOR MEDISONO P3MUS050042020-12-28
B369MUS05005MedisonoTRANSVAGINAL PROBE MODEL PB-E611-2 FOR MEDISONO P3MUS050052020-12-28
B369MUS05006MedisonoENDORECTAL PROBE MODEL PB-E741-2 FOR MEDISONO P3MUS050062020-12-28
B369MUS05007MedisonoENDORECTAL PROBE MODEL PB-V563-2 FOR MEDISONO P3VMUS050072020-12-28
B369MUS05008MedisonoCONVEX ARRAY PROBE MODEL PB-C361-2 FOR MEDISONO P3MUS050082020-12-28
B369MUS05009MedisonoLINEAR ARRAY PROBE MODEL PB-L761-2 FOR MEDISONO P3MUS050092020-12-28
B369MUS05010MedisonoLINEAR ARRAY PROBE MODEL PB-L743-2 FOR MEDISONO P3MUS050102020-12-28
B369MUS05011MedisonoMICRO-CONVEX PROBE MODEL PB-C611-2 FOR MEDISONO P3MUS050112020-12-28
B369MUS05020MedisonoCONVEX ARRAY PROBE MODEL PB-C352UB FOR MEDISONO P1MUS050202020-12-28
B369MUS05021MedisonoMICRO-CONVEX ARRAY PROBE MODEL PB-C612UB FOR MEDISMUS050212020-12-28
B369MUS05022MedisonoMICRO-CONVEX ARRAY PROBE MODEL PB-C422UB FOR MEDISMUS050222020-12-28
B369MUS05023MedisonoLINEAR ARRAY PROBE MODEL PB-L742UB FOR MEDISONO P1MUS050232020-12-28
B369MUS05024MedisonoLINEAR ARRAY PROBE MODEL PB-L1042UB FOR MEDISONO PMUS050242020-12-28
B369MUS05025MedisonoLINEAR ARRAY PROBE MODEL PB-L552UB FOR MEDISONO P1MUS050252020-12-28
B369MUS05026MedisonoTRANSVAGINAL ARRAY PROBE MODEL PB-E612UB FOR MEDISMUS050262020-12-28
B369MUS05030MedisonoCONVEX ARRAY PROBE MODEL PB-C352UB FOR MEDISONO P1MUS050302020-12-28
B369MUS05031MedisonoMICRO-CONVEX ARRAY PROBE MODEL PB-C612UB FOR MEDISMUS050312020-12-28

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Primary DI, Brand, Company table
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