Electro-Mesh Panel

GUDID B872EMSP480

Electro-Mesh Panel 4x8

PRIZM MEDICAL, INC.

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: B872EMSP480
• NIH Device Record Key: f95f323e-6797-41cb-b8e1-5328f58ec5da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electro-Mesh Panel
• Version Model Number: EMSP48
• Company DUNS: 790271118
• Company Name: PRIZM MEDICAL, 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B872EMSP480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944487

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: 2024-06-14
• Device Publish Date: 2024-06-06

On-Brand Devices [Electro-Mesh Panel]

• B872EMSP480: Electro-Mesh Panel 4x8
• B872EMSP440: Electro-Mesh Panel 4x4
• B872EMSP240: Electro-Mesh Panel 1.5x4