FDA.reportPublic FDA data

GI Genius

Primary DI
10884521821545
Brand
GI Genius
Company
Covidien LP
Model
CB1708-RFB
Device description
Intelligent Endoscopy Module , Refurbished
Published
2021-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QNPGastrointesinal lesion software detection system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNPGastrointesinal Lesion Software Detection SystemGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521821545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452182154510884521821545

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image interpretive unitAn electrically-powered computing unit intended to analyse endoscopic video images to automatically detect and localize suspected abnormalities and lesions (e.g., polyps) in real-time. It interfaces with an endoscopic video image processing unit and display monitor, and will typically use artificial intelligence (AI)/deep learning software to identify abnormalities and overlay visual flags/markers on video images to highlight regions of interest to clinicians.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature14 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08
10884521845985INVOSPMC71VP-GE2025-07-03
10884521063150ILA3948L2015-08-28
10884521102422Steel88862345-532015-08-31
10884521103863TaperGuard18780S2016-09-24
10884521211933Shiley5-182372017-05-10
10884521543799SigniaSIGPSHELL2017-08-08
10884521713208EdgeE1455B2016-11-18
10884521713277EdgeE1475X2016-11-18
20884521103631Mallinckrodt5-182372015-08-28
20884521105574Mallinckrodt5-185412015-08-28
40884521105578Shiley5-185412018-05-16
10884521543881SigniaSIGMRET2017-07-24
10884521543874SigniaSIGRIG2017-07-31
10884521620254Shiley862342016-09-24
10884521543812SigniaSIGADAPTXL2017-08-08
10884521101098NellcorMAXPACAI2016-09-24
10884521543782SigniaSIGPHANDLE2017-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05065010840065CADDIEODIN MEDICAL LIMITEDQNP2025-10-16
07290020140012MAGENTIQ-COLO (ME-APDS)MAGENTIQ EYE LTDQNP2025-08-21
08055060110376ColonPRO™ 4.0LINKVERSE SRLQNP2025-04-01
78055060110375ColonPRO™ 4.0LINKVERSE SRLQNP2025-04-01
08055060110345ColonPRO™ 4.0LINKVERSE SRLQNP2024-10-14
78055060110344ColonPRO™ 4.0LINKVERSE SRLQNP2024-10-14
00860010168417SKOUT systemIterative Scopes, Inc.QNP2024-10-10
15065010840024CADDIEODIN MEDICAL LIMITEDQNP2024-10-01
08055060110338GI Genius™ Module 300LINKVERSE SRLQNP2024-09-22
08055060110291ColonPRO™ 4.0LINKVERSE SRLQNP2024-02-26
78055060110290ColonPRO™ 4.0LINKVERSE SRLQNP2024-02-26
08055060110314GI Genius™ Module 100LINKVERSE SRLQNP2024-02-26
08055060110321GI Genius™ Module 200LINKVERSE SRLQNP2024-02-26
04547410541199FUJIFILMFUJIFILM CORPORATIONQNP2024-02-16
10884521844537GI GeniusCovidien LPQNP2023-09-18
10884521844544GI GeniusCovidien LPQNP2023-09-18
08055060110178USB K-switchLINKVERSE SRLQNP2023-08-11
08055060110185FootswitchLINKVERSE SRLQNP2023-08-11
00860010168400SKOUT systemIterative Scopes, Inc.QNP2023-05-23
06973770840012EndoScreenerChengdu Wision Medical Device Co., Ltd.QNP2022-04-26
10884521807259GI GeniusCovidien LPQNP2021-04-30