DeltaScan Patch 009.000.B

GUDID 08719326465340

Prolira B.V.

Electroencephalographic electrode cap, single-use

• Primary Device ID: 08719326465340
• NIH Device Record Key: 2bb35f52-2b2d-49d5-be78-906f6bd90aa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DeltaScan Patch
• Version Model Number: R2
• Catalog Number: 009.000.B
• Company DUNS: 491559325
• Company Name: Prolira B.V.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719326465340 [Primary]

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: 2
• Public Version Date: 2023-10-11
• Device Publish Date: 2023-05-11

On-Brand Devices [DeltaScan Patch]

• 87193264653408: R2
• 08719326465340: R2