G120000D

GUDID 00724995227340

gi400 Electrosurgery Unit Evaluation Kit

US Endoscopy

Inert gas-enhanced electrosurgical system
Primary Device ID00724995227340
NIH Device Record Key62a3e7ed-9ac3-4910-a121-429bd601b4e7
Commercial Distribution StatusIn Commercial Distribution
Version Model Numbergi4000
Catalog NumberG120000D
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

Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100724995227340 [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 Date2023-11-21
Device Publish Date2023-11-13

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00724995244576 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/12mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244583 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/15mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244590 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/18mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244606 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/6mm no wire is made of nylon and is a progressive stage balloon capable of th
00724995244613 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/8mm no wire is made of nylon and is a progressive stage balloon capable of th

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