G1110001

GUDID 00724995180256

The gi4000 Electrosurgical Unit 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: 00724995180256
• NIH Device Record Key: d01f9b79-6d3a-4139-ad53-00e92b12aad9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: gi4000
• Catalog Number: G1110001
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)548-4873
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995180256 [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: 2022-02-28
• Device Publish Date: 2022-02-18

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