BTL Cellutone handpiece

GUDID B108714GUNALXC0

BTL INDUSTRIES LIMITED

Electric massager

• Primary Device ID: B108714GUNALXC0
• NIH Device Record Key: 6e37e38e-fcda-4bbf-b79a-848e5cfa790d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BTL Cellutone handpiece
• Version Model Number: BTL Cellutone handpiece
• 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	B108714GUNALXC0 [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 handpiece]

• B108714GUNALXCENUS0: BTL Cellutone handpiece
• B108714GUNALXC1040: BTL Cellutone handpiece
• B108714GUNALXC0: BTL Cellutone handpiece