RM Electrode - 10 pack

GUDID 00860012396115

Ten units of disposable corneal contact lens electrode used for measurement and recording of full field electroretinography (ERG) signals.

Retmap, Inc.

Electroretinograph electrode

• Primary Device ID: 00860012396115
• NIH Device Record Key: acfc763c-264b-409f-b8bf-ecd2722367c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RM Electrode - 10 pack
• Version Model Number: RMH 23-01
• Company DUNS: 963712646
• Company Name: Retmap, Inc.
• Device Count: 10
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012396108 [Unit of Use]
GS1	00860012396115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232273

FDA Product Code

• HLZ: Electrode, Corneal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-17
• Device Publish Date: 2024-12-09