EMFEMME V tip

GUDID B108785TIPVMUS00

BTL INDUSTRIES LIMITED

Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system

• Primary Device ID: B108785TIPVMUS00
• NIH Device Record Key: c61b7dbe-5038-41f7-a64f-3b37b06a02ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMFEMME V tip
• Version Model Number: EMFEMME V tip
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	B108785TIPVMUS00 [Primary]

FDA Product Code

• PBX: Massager, Vacuum, Radio Frequency Induced Heat

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: 2022-03-14
• Device Publish Date: 2022-03-04

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• 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