X-Surge

GUDID 00877972006718

GENICON, INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 00877972006718
• NIH Device Record Key: d49d81e1-f0af-44a8-83b4-61088567af5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Surge
• Version Model Number: 590-005-013
• Company DUNS: 079805400
• Company Name: GENICON, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877972006718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171752

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-22
• Device Publish Date: 2019-11-14

On-Brand Devices [X-Surge]

• 00877972007210: 590-005-005
• 00877972006732: 590-005-001
• 00877972006725: 590-005-014
• 00877972006695: 590-005-010
• 00877972006718: 590-005-013