BTL Cellutone

GUDID B108744POCTENUS0

BTL INDUSTRIES LIMITED

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• Primary Device ID: B108744POCTENUS0
• NIH Device Record Key: 700f463e-c3eb-48f8-ab93-9fe3f77bb076
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BTL Cellutone
• Version Model Number: BTL Cellutone
• Company DUNS: 733532951
• Company Name: BTL INDUSTRIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	B108744POCTENUS0 [Primary]

FDA Product Code

• IRO: Vibrator, Therapeutic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-23
• Device Publish Date: 2017-01-12

On-Brand Devices [BTL Cellutone]

• B108744POCTENUS1030: BTL Cellutone
• B108744POCTENUS0: BTL Cellutone