MedCare Visions OL5100046

GUDID 00816022023596

Disposable OL5100046 aEEG Needle Electrode Set, 12mm x29ga, 40", (Pack of 40)

IMPULSE MEDICAL TECHNOLOGIES, INC.

Subdermal needle electrode

• Primary Device ID: 00816022023596
• NIH Device Record Key: 4ddc66f7-85fd-441a-b3a0-e3de2fdb1a3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedCare Visions
• Version Model Number: PRO-EBW
• Catalog Number: OL5100046
• Company DUNS: 080015502
• Company Name: IMPULSE MEDICAL TECHNOLOGIES, 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: true
• 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
GS1	00816022023596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020910

FDA Product Code

• GXZ: Electrode, Needle

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: 2018-04-30
• Device Publish Date: 2018-03-30

On-Brand Devices [MedCare Visions]

• 00816022023602: Disposable OL4162056 1-channel aEEG Needle Electrode Set, 12mm x29ga, 40", (20)
• 00816022023596: Disposable OL5100046 aEEG Needle Electrode Set, 12mm x29ga, 40", (Pack of 40)