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

Devices Manufactured by US Endoscopy

10724995197688 - DEFENDO2024-07-23 The single-use DEFENDO Olympus EUS Air Water Suction valve - 2-piece kit is used to control the air/water function of an endosco
10724995217409 - DEFENDO2024-07-23 The single-use DEFENDO Olympus EUS Air Water Suction Valve - Linear Biopsy Valve 3-piece kit
10724995183278 - VIA2024-06-11 The VIA Procedure Kit-custom includes transport pad, gauze, Via Basin, enzymatic sponge, lubricating jelly, suction tubing, gown
00724995227340 - NA2023-11-21 gi400 Electrosurgery Unit Evaluation Kit
00724995199296 - truFreeze2023-07-19 truFreeze Spray Cryotherapy System Console allows for delivery of liquid nitrogen (LN2) during both active and passive venting p
20724995221618 - Ascendo2023-07-19 Ascendo Submucosal Lifting Agent
10724995216839 - Torrent2023-05-15 The Torrent irrigation scope connector is used with the Torrent irrigation tubing to provide irrigation fluids such as sterile w
50724995216844 - Torrent2023-05-15 The Torrent irrigation scope connector Pentax is used with the Torrent irrigation tubing to provide irrigation fluids such as st

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.