BTL Vanquish ME

GUDID B108713POUNITUS0

BTL INDUSTRIES LIMITED

Hyperthermia system gantry Hyperthermia system gantry

• Primary Device ID: B108713POUNITUS0
• NIH Device Record Key: af5686e4-4483-42e7-92ca-f79980239128
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BTL Vanquish ME
• Version Model Number: BTL Vanquish ME
• 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	B108713POUNITUS0 [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

Devices Manufactured by BTL INDUSTRIES LIMITED

• B108043PO30WMUS00 - LS-6000: 2024-04-01
• B108451POSCAEL2MUS00 - Scanning System for LS-6000: 2024-04-01
• B108899AP2C2MUS20 - Small applicator: 2023-12-18
• B108899AP2C45MUS10 - Edge applicator: 2023-12-18
• B108899APC1ENUS0140 - Large applicator: 2023-12-18
• B108899PO11C1ENUS0140 - EMSCULPT NEO: 2023-12-18
• B108785PO8MUS00 - BTL-785F: 2023-12-11
• B108785PO9MUS00 - BTL-785F: 2023-12-11