FDA.reportPublic FDA data

G-EYE Colonoscope

Primary DI
07290018671085
Brand
G-EYE Colonoscope
Company
SMART MEDICAL SYSTEMS LTD
Model
G-EYEH190I
Catalog number
40-550
Device description
The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning.
Published
2020-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
K192588000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192588000G-EYE SystemSmart Medical Systems , Ltd.2020-04-15FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018671085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018671085072900186710857290018671085

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-47 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649905544
Device count
1
DM exempt
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018671658NaviAid™ ABCABC23-0102024-01-14
17290018671662NaviAid™ ABCABC23-0102024-01-14
07290018671214G-EYE ColonoscopeG-EYEHQ190L40-5602023-07-18
07290018671221G-EYE ColonoscopeG-EYEHQ190I40-5602023-07-18
07290018671238G-EYE ColonoscopeG-EYEH190L40-5602023-07-18
07290018671245G-EYE ColonoscopeG-EYEH190I40-5602023-07-18
07290018671252G-EYE ColonoscopeG-EYEQ180AL40-5602023-07-18
07290018671269G-EYE ColonoscopeG-EYEQ180AI40-5602023-07-18
07290018671276G-EYE ColonoscopeG-EYEH180AL40-5602023-07-18
07290018671283G-EYE ColonoscopeG-EYEH180AI40-5602023-07-18
07290018671009G-EYE ColonoscopeG-EYE760R-V/L40-5962020-12-02
07290018671016G-EYE ColonoscopeG-EYE760ZP-V/L40-5962020-12-02
07290018671023G-EYE ColonoscopeG-EYE760P-V/L40-5962020-12-02
07290018671030G-EYE ColonoscopeG-EYE760S-V/L40-5962020-12-02
07290018671047G-EYE ColonoscopeG-EYE760Z-V/L40-5962020-12-02
07290018671504NaviAid™ SPARKCSPARKC40-0162020-12-02
07290018671634NaviAid™ ABAB-R31-0102020-12-02
07290018671054G-EYE ColonoscopeG-EYEHQ190L40-5502020-12-01
07290018671061G-EYE ColonoscopeG-EYEHQ190I40-5502020-12-01
07290018671078G-EYE ColonoscopeG-EYEH190L40-5502020-12-01

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