G120000D

GUDID 00724995227340

gi400 Electrosurgery Unit Evaluation Kit

US Endoscopy

Inert gas-enhanced electrosurgical system

• Primary Device ID: 00724995227340
• NIH Device Record Key: 62a3e7ed-9ac3-4910-a121-429bd601b4e7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: gi4000
• Catalog Number: G120000D
• 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

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995227340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172805

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: 2023-11-21
• Device Publish Date: 2023-11-13

Devices Manufactured by US Endoscopy

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• 10724995243767 - Exacto Mundo: 2025-08-27 The Exacto Mundo cold snare is intended to be used without diathermic energy for the endoscopic resection of polyp tissue in the
• 10724995244535 - Lumiflex: 2025-08-27 LUMIFLEX BALLOON INFLATOR
• 00724995244545 - Lumiflex: 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/6mm wire is made of nylon and is a progressive stage balloon capable of three
• 00724995244552 - Lumiflex: 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/8mm wire is made of nylon and is a progressive stage balloon capable of three
• 00724995244569 - Lumiflex: 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/10mm wire is made of nylon and is a progressive stage balloon capable of thre
• 00724995244576 - Lumiflex: 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/12mm wire is made of nylon and is a progressive stage balloon capable of thre
• 00724995244583 - Lumiflex: 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/15mm wire is made of nylon and is a progressive stage balloon capable of thre