Precision DME

GUDID B1870441

Dual conductive pad, 3 in. x 5 in., 2/package

NEUROTRON MEDICAL, INC.

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• Primary Device ID: B1870441
• NIH Device Record Key: 4c62c4fb-9289-4279-aa49-3209ea589cba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision DME
• Version Model Number: PLB030-3050D
• Company DUNS: 147018519
• Company Name: NEUROTRON MEDICAL, INC.
• Device Count: 2
• 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: 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	B1870440 [Unit of Use]
HIBCC	B1870441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053214

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: 2017-04-26

On-Brand Devices [Precision DME]

• B1870441: Dual conductive pad, 3 in. x 5 in., 2/package
• B1870430: Conductive pad, 4 in. x 11.5 in., 1/package