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 ID: 00724995180263
• NIH Device Record Key: 9c53a0ea-051f-4679-999c-123588532fbc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: gi4000
• Catalog Number: G1200000
• Company DUNS: 627879687
• Company Name: US Endoscopy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995180263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172805
• Premarket Notification: K192265

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-28
• Device Publish Date: 2022-02-18

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• 00724995199302 - truFreeze: 2024-12-03 truFreeze Spray Cryotherapy Console - Evaluation Unit
• 10724995220058 - Roth Net: 2024-12-03 The Roth Net retriever-360 product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and ca
• 10724995220065 - Roth Net Platinum: 2024-12-03 The disposable Roth Net Platinum universal retrieval device product line is used in the endoscopic retrieval of foreign body, fo
• 00724995228897 - CO2MPACT: 2024-12-03 CO2MPACT EVALUATION KIT. The CO2MPACT Endoscopic Insufflator System is designed to use CO2 as a distention media in the gastroin
• 10724995231719 - DEFENDO: 2024-12-03 The single-use DEFENDO Olympus EUS Air Water Suction , Biopsy valve - 3-piece kit is used to control the air/water function of a
• 00724995226732 - Padlock Clip: 2024-11-08 The Padlock Clip EFTR Kit includes the EFTR Device, Raptor grasping device, and (TouchSoft Coagulator Probe.