BTL EMSCULPT

GUDID B108799PO2166ENUS0130

BTL INDUSTRIES LIMITED

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• Primary Device ID: B108799PO2166ENUS0130
• NIH Device Record Key: 10d78c33-340e-4e75-b1c2-9e184b402de2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BTL EMSCULPT
• Version Model Number: BTL EMSCULPT
• 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	B108799PO2166ENUS0130 [Primary]

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

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: 2019-07-17
• Device Publish Date: 2019-07-09

On-Brand Devices [BTL EMSCULPT]

• B108799PO2166ENUS0120: BTL EMSCULPT
• B108799PO2166ENUS0110: BTL EMSCULPT
• B108799PO2166ENUS0100: BTL EMSCULPT
• B108799PO2166ENUS0130: BTL EMSCULPT