Pure-Vu EVS GASTRO KIT, Single Pack PV-GST-04-0

GUDID 05060513700403

Pure-Vu EVS GASTRO DISPOSABLE KIT, Single Pack

MOTUS GI MEDICAL TECHNOLOGIES LTD

Colonic lavage system, powered-flow
Primary Device ID05060513700403
NIH Device Record Keyb8e95783-5930-4de6-9265-3b90a56e3e46
Commercial Distribution StatusIn Commercial Distribution
Brand NamePure-Vu EVS GASTRO KIT, Single Pack
Version Model NumberPV-GST-04-0
Catalog NumberPV-GST-04-0
Company DUNS532775983
Company NameMOTUS GI MEDICAL TECHNOLOGIES LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060513700403 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDFColonoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-10
Device Publish Date2023-11-02

Devices Manufactured by MOTUS GI MEDICAL TECHNOLOGIES LTD

05060513700397 - Pure-Vu EVS GASTRO KIT 5 Pack2023-11-10 Pure-Vu EVS GASTRO DISPOSABLE KIT 5 Pack
05060513700403 - Pure-Vu EVS GASTRO KIT, Single Pack2023-11-10Pure-Vu EVS GASTRO DISPOSABLE KIT, Single Pack
05060513700403 - Pure-Vu EVS GASTRO KIT, Single Pack2023-11-10 Pure-Vu EVS GASTRO DISPOSABLE KIT, Single Pack
05060513700410 - Pure-Vu EVS COLON KIT, 5 Pack2023-11-10 Pure-Vu EVS Disposable Colon Kit for use with the Pure-Vu System. (5 Pack)
05060513700427 - Pure-Vu EVS Colon Kit, Single Pack2023-11-10 Pure-Vu EVS DISPOSABLE COLON KIT for use with the Pure-Vu System.
05060513700144 - Pure-Vu EVS System Disposable2023-09-14 EVS Disposable Colon Pack (5)
05060513700151 - Pure-Vu EVS System2023-09-14 (1) EVS Workstation with foot pedal
05060513700168 - MOTUS GI Endoscopy Cart (Accessory)2023-09-14 Endoscopy Cart Accessory used with the MOTUS GI Workstation
05060513700199 - Pure-Vu EVS Waste Bag (Accessory)2023-09-14 EVS Waste Bag (Accessory)

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