Slendertone Replacement Abdominal Toning Gel Pads 0706-9607

GUDID 05099058706007

BIO-MEDICAL RESEARCH LIMITED

Transcutaneous electrical stimulation electrode

• Primary Device ID: 05099058706007
• NIH Device Record Key: 2b6fe1a3-09c5-4488-8fcc-7d3ca0b9c6e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slendertone Replacement Abdominal Toning Gel Pads
• Version Model Number: 732 / 733
• Catalog Number: 0706-9607
• Company DUNS: 987904356
• Company Name: BIO-MEDICAL RESEARCH 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	05099058706007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130987

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Slendertone Replacement Abdominal Toning Gel Pads]

• 05099058732006: 732 / 733
• 05099058706007: 732 / 733
• 05099058732013: 732 / 733