Medical Science Products TS-1211

GUDID 10851610008347

Digital TENS device

SAUVRE INTERNATIONAL, LTD.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 10851610008347
• NIH Device Record Key: 85ea2a7c-c80b-4c3e-b77b-4b345fbfb8dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medical Science Products
• Version Model Number: TS-1211
• Catalog Number: TS-1211
• Company DUNS: 080557421
• Company Name: SAUVRE INTERNATIONAL, LTD.
• 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 Dimensions

• Width: 60 Millimeter
• Width: 60 Millimeter
• Width: 60 Millimeter
• Width: 60 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851610008319 [Primary]
GS1	00851610008340 [Package]; Contains: 00851610008319; Package: Bag [1 Units]; In Commercial Distribution
GS1	10851610008347 [Package]; Contains: 00851610008340; Package: Box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071624

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

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: 2019-10-23
• Device Publish Date: 2018-05-29

On-Brand Devices [Medical Science Products]

• 00864666000367: Transcutaneous electrical stimulation electrode, Butterfly, 110x150mm, Foam material
• 10851610008002: Transcutaneous electrical stimulation electrode, Square, 50x90mm, Foam material
• 10864666000395: Transcutaneous electrical stimulation electrode, Square, 50x50mm, Foam material
• 10864666000326: Transcutaneous electrical stimulation electrode, Square, 40x40mm
• 00851610008326: Analog TENS device
• 10851610008347: Digital TENS device
• 10851610008026: Transcutaneous electrical stimulation electrode, Square, 50x50mm, Cloth material