Exilis

GUDID B108715POEXILISUTENUS0

BTL INDUSTRIES LIMITED

Electrosurgical system generator

• Primary Device ID: B108715POEXILISUTENUS0
• NIH Device Record Key: 5620caa9-7025-4bb9-be1c-1c5a588762a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exilis
• Version Model Number: BTL Exilis Ultra
• Company DUNS: 733532951
• Company Name: BTL INDUSTRIES LIMITED
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B108715POEXILISUTENUS0 [Primary]

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-12

On-Brand Devices [Exilis]

• B108715POEXILISUTENUS0: BTL Exilis Ultra
• B108715POEXILISF2ENUS0: Exilis Ultra 360