EMSCULPT NEO

GUDID B108899PO11C1ENUS0100

BTL INDUSTRIES LIMITED

Multi-modality hyperthermia system

• Primary Device ID: B108899PO11C1ENUS0100
• NIH Device Record Key: 12ac5cb5-4604-4a3b-9562-8b6f2029dfe4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMSCULPT NEO
• Version Model Number: EMSCULPT NEO
• 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	B108899PO11C1ENUS0100 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-10
• Device Publish Date: 2020-03-02

On-Brand Devices [EMSCULPT NEO]

• B108899PO11C1ENUS0100: EMSCULPT NEO
• B108899PO11C1ENUS0110: EMSCULPT NEO
• B108899PO11C1ENUS0120: EMSCULPT NEO
• B108899PO11C1ENUS0130: EMSCULPT NEO
• B108899PO11C1ENUS0140: EMSCULPT NEO
• B108899PO11C1ENUS0150: EMSCULPT NEO