ADVANCE

GUDID 10851221006206

Sural Biosensor (Left) Individual

NEUROMETRIX, INC.

Electrode conductive medium

• Primary Device ID: 10851221006206
• NIH Device Record Key: 01a6820d-c61e-41a6-a92d-62f6d1208479
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVANCE
• Version Model Number: NC-S82
• Company DUNS: 957536014
• Company Name: NEUROMETRIX, INC.
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-314-2781
• Email: rainer_maas@neurometrix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851221006209 [Primary]
GS1	10851221006206 [Package]; Contains: 00851221006209; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041320

FDA Product Code

• JXE: Device, Nerve Conduction Velocity Measurement

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: 2018-10-22
• Device Publish Date: 2016-09-08

On-Brand Devices [ADVANCE]

• 00851221006315: Ulnar Elbow Biosensor Kit (Right) Case - Comprised of NC-S71 and NC-S73 DI Numbers 0085122100615
• 00851221006308: Ulnar Elbow Biosensor Kit (Left) Case - Comprised of NC-S72 and NC-S74 DI Numbers 00851221006162
• 10851221006244: Median-Ulnar Biosensor (Left) Individual
• 10851221006237: Median-Ulnar Biosensor (Right) Individual
• 10851221006220: Median Motor-Sensory (over Muscle) Biosensor (Left) Individual
• 10851221006213: Median Motor-Sensory (over Muscle) Biosensor (Right) Individual
• 10851221006206: Sural Biosensor (Left) Individual
• 10851221006190: Sural Biosensor (Right) Individual
• 00851221006186: Ulnar Elbow Biosensor (Left) Individual
• 00851221006179: Ulnar Elbow Biosensor (Right) Individual
• 10851221006169: Ulnar Wrist Biosensor (Left) Individual
• 00851221006155: Ulnar Wrist Biosensor (Right) Individual
• 10851221006145: Tibial Biosensor (Left) Individual
• 10851221006138: Tibial Biosensor (Right) Individual
• 10851221006121: Superficial Peroneal Biosensor (Left) Individual
• 10851221006114: Superficial Peroneal Biosensor (Right) Individual
• 10851221006107: Peroneal Biosensor (Left) Individual
• 00851221006094: Peroneal Biosensor (Right) Individual