00713100

GUDID 00724995195045

The gi4000 Introduction Kit contains Argon Gas Cainster, ArConnect Argon Probe Connector, ArC Smart Probe, Touchsoft Coagulator Monopolar Probe, Active Cord and a Water Bottle Holder.

US Endoscopy

Argon-enhanced electrosurgical system
Primary Device ID00724995195045
NIH Device Record Key3fa7373f-7b0b-42dd-9f7e-2dffe3ffb24e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number00713100
Catalog Number00713100
Company DUNS627879687
Company NameUS Endoscopy
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
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
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature limit 10-30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Humidity Limit 10%-75% noncondensing

Device Identifiers

Device Issuing AgencyDevice ID
GS100724995195045 [Primary]

FDA Product Code

NWIElectrosurgical electrode kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-18
Device Publish Date2020-09-10

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00724995244545 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/6mm wire is made of nylon and is a progressive stage balloon capable of three
00724995244552 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/8mm wire is made of nylon and is a progressive stage balloon capable of three
00724995244569 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/10mm wire is made of nylon and is a progressive stage balloon capable of thre
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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