COMBY EEG CAP BYP10G

GUDID 03858894153411

Bypass electrodes Ag/AgCl, green

PAMEL d.o.o.

Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable Analytical scalp electrode, reusable

• Primary Device ID: 03858894153411
• NIH Device Record Key: 555be664-a079-40ba-b3ae-18a22bc29df0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMBY EEG CAP
• Version Model Number: Bypass electrodes Ag/AgCl, green
• Catalog Number: BYP10G
• Company DUNS: 643949162
• Company Name: PAMEL d.o.o.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	03858894153411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211315

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: 2023-08-24
• Device Publish Date: 2023-08-16

On-Brand Devices [COMBY EEG CAP]

• 03858894153183: Electrode CUP with 120cm lead wire and sintered Ag/AgCl electrode
• 03858894151974: Comby EEG cap with 22 Ag/AgCl electrodes, size 57-62
• 03858894151967: Comby EEG cap with 22 Ag/AgCl sintered electrodes, size 52-57
• 03858894151950: Comby EEG cap with 22 Ag/AgCl sintered electrodes, size 47-52
• 03858894154135: Chest belt for EEG cap for adults
• 03858894153442: Bypass electrodes Ag/AgCl, yellow
• 03858894153428: Bypass electrodes Ag/AgCl, red
• 03858894153411: Bypass electrodes Ag/AgCl, green
• 03858894153398: Bypass electrodes Ag/AgCl
• 03858894152834: Comby EEG cap with 34 Ag/AgCl sintered electrodes, size 57-62
• 03858894152827: Comby EEG cap with 34 Ag/AgCl sintered electrodes, size 52-57
• 03858894152810: Comby EEG cap with 34 Ag/AgCl sintered electrodes, size 47-52