SOLO SCOPE Video Controller

Primary DI
17290016992172
Brand
SOLO SCOPE Video Controller
Company
G.I. VIEW LTD
Model
1
Catalog number
MPK02157
Device description
SOLO SCOPE Video Controller
Published
2026-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDFColonoscope And Accessories, Flexible/Rigid
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261015000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290016992186PackageGS11In Commercial Distribution
17290016992172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2729001699218627290016992186
1729001699217217290016992172

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video colonoscope, single-useAn 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 typically to examine the colon (e.g., diseases on the colon) or colon contents (e.g., blood in stools). It may be designed to be manually inserted or designed with features to assist/power insertion (e.g., push/pull double-balloons, powered propelling mechanism). Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+972509898204racheli@giview.com

Regulatory Flags#

DUNS number
533751681
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
17290016992158SOLO SCOPE Disposable Colonoscope1MPK021512026-08-25
07290016992113Aer-O-Scope Disposable ColonoscopeDMASA028002026-05-27
07290016992021Aer-O-Scope Daily Tube Convenience KitRev BMASA025022017-08-01
07290016992038Aer-O-Scope Water BottleRev AMASA024742017-08-01
07290016992007Aer-O-Scope WorkstationRev BMASA01012017-08-01
17290016992028Aer-O-Scope Daily Tube Convenience KitRev BMASA025022017-08-01
17290016992035Aer-O-Scope Water BottleRev AMASA024742017-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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