X-Surge

GUDID 00877972006725

GENICON, INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 00877972006725
• NIH Device Record Key: 282a684d-5208-42ea-9fc0-748f4dc75dd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Surge
• Version Model Number: 590-005-014
• 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: 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877972006725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171752

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00877972006725]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-21
• Device Publish Date: 2018-10-03

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