Micro-Z II

GUDID B872MZS2KIT20

PRIZM MEDICAL, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: B872MZS2KIT20
• NIH Device Record Key: 0a5bda5e-008b-44f4-8899-1dec2d50e122
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro-Z II
• Version Model Number: MZ2KIT2
• Company DUNS: 790271118
• Company Name: PRIZM MEDICAL, INC.
• Device Count: 250
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B872MZS2KIT20 [Primary]
HIBCC	C20011 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024181

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-15
• Device Publish Date: 2020-05-07

On-Brand Devices [Micro-Z II]

• B872MZS2KIT20: MZ2KIT2
• D20007: MZ2KIT2