G1200000

GUDID 00724995180263

The gi4000 Electrosurgical Unit -Loaner is designed specifically for flexible endoscopy and has Argon, Monopolar, Bipolar and Lavage functions all built into the one easy-to-use, compact unit.

US Endoscopy

Argon-enhanced electrosurgical system
Primary Device ID00724995180263
NIH Device Record Key9c53a0ea-051f-4679-999c-123588532fbc
Commercial Distribution StatusIn Commercial Distribution
Version Model Numbergi4000
Catalog NumberG1200000
Company DUNS627879687
Company NameUS Endoscopy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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Device Identifiers

Device Issuing AgencyDevice ID
GS100724995180263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, cutting & coagulation & accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-28
Device Publish Date2022-02-18

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10724995243767 - Exacto Mundo2025-08-27 The Exacto Mundo cold snare is intended to be used without diathermic energy for the endoscopic resection of polyp tissue in the
10724995244535 - Lumiflex2025-08-27 LUMIFLEX BALLOON INFLATOR
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