FDA.reportPublic FDA data

LithAssist

Primary DI
00827002238107
Brand
LithAssist
Company
COOK INCORPORATED
Model
G23810
Catalog number
LA-116038
Device description
LithAssist Suction Control for Laser Lithotripsy
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQTEVACUATOR, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQTEvacuator, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002238107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002238107008270022381078270022381070827002238107

GMDN Terms#

Term, Definition table
TermDefinition
Laser lithotripsy fibre/suction guideA sterile device intended to be inserted through the working channel of a rigid nephroscope during laser lithotripsy to function as a channel for insertion of the laser fibre of an endotherapy laser beam guide, and for removal of debris (e.g., fluid, calculi fragments) when connected to a vacuum source. It typically consists of a thin hollow tube inserted through a handle, which enable entry of the laser fibre and connection to vacuum tubing. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002012585KopansG01258DKBL-21-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973356551455ProxivaShenzhen Trious Medical Technology Co., LtdKQT2026-08-18
06973356551721TriousShenzhen Trious Medical Technology Co., LtdKQT2026-06-23
04055207054390NARichard Wolf GmbHKQT2026-05-19
06973356557754TriousShenzhen Trious Medical Technology Co., Ltd.KQT2026-03-25
06973356557907PUSENShenzhen Trious Medical Technology Co., Ltd.KQT2025-12-08
04055207011911NARichard Wolf GmbHKQT2024-08-19
00724995203306BioVacUS EndoscopyKQT2020-11-23
10724995203303BioVacUS EndoscopyKQT2020-11-23
00801741049057Ellik Bladder EvacuatorC. R. Bard, Inc.KQT2020-09-22
00801741080647Bladder EvacuatorC. R. Bard, Inc.KQT2020-09-22
00812261019413Tur Vac ALLWIN MEDICAL DEVICES, INC.KQT2020-09-22
00724995183783BioVacUS EndoscopyKQT2020-04-01
00724995183790BioVacUS EndoscopyKQT2020-04-01
00724995183806BioVacUS EndoscopyKQT2020-04-01
10724995183780BioVacUS EndoscopyKQT2020-04-01
10724995183797BioVacUS EndoscopyKQT2020-04-01
10724995183803BioVacUS EndoscopyKQT2020-04-01
00860002476100Intussusception Air Reduction Kit with Blue tipGRI MEDICAL PRODUCTS INCKQT2019-12-18
00860002476117Intussusception Air Reduction Kit with Pink TipGRI MEDICAL PRODUCTS INCKQT2019-12-18
00860002476124Intussusception Air Reduction kit, no tipGRI MEDICAL PRODUCTS INCKQT2019-12-18
00860002476131Intussusception Air Reduction Bulb & GaugeGRI MEDICAL PRODUCTS INCKQT2019-12-18
00860002476148Intussusception Air Reduction Bulb & Gauge with Plastic CaseGRI MEDICAL PRODUCTS INCKQT2019-12-18
00860002476155Occlusion DiscGRI MEDICAL PRODUCTS INCKQT2019-12-18
00860002476162Intussusception Pressure Relief ValveGRI MEDICAL PRODUCTS INCKQT2019-12-18
00841436104579CollectEVACCIVCO MEDICAL INSTRUMENTS CO., INC.KQT2018-01-03
00841436108614Cook CollectEVACCIVCO MEDICAL INSTRUMENTS CO., INC.KQT2018-01-03
00827002515499Cook CollectEVACCIVCO MEDICAL INSTRUMENTS CO., INC.KQT2018-01-03
00848657013307AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQT2017-11-28
00848657016889AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQT2017-11-28
00821925001053ToomeyGyrus ACMI, LLCKQT2016-10-11