Slendertone Replacement Abdominal Toning Gel Pads 0706-9632

GUDID 05099058732013

BIO-MEDICAL RESEARCH LIMITED

Transcutaneous electrical stimulation electrode

• Primary Device ID: 05099058732013
• NIH Device Record Key: ff2d818e-3df9-47e6-874f-62f3aa5df410
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slendertone Replacement Abdominal Toning Gel Pads
• Version Model Number: 732 / 733
• Catalog Number: 0706-9632
• 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	05099058732013 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-14
• Device Publish Date: 2020-07-06

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

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