Cadwell Single Disc Electrode

GUDID 00840067101568

CADWELL INDUSTRIES, INC.

Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode

• Primary Device ID: 00840067101568
• NIH Device Record Key: 5dee86c9-2a57-4dce-9cc8-6e3ad4075af4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cadwell Single Disc Electrode
• Version Model Number: 302787-200
• Company DUNS: 098554157
• Company Name: CADWELL INDUSTRIES, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Customer Support Contacts

• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com

Device Dimensions

• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch
• Length: 40 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067101568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933802

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-05

On-Brand Devices [Cadwell Single Disc Electrode]

• 00840067101599: 302087-200
• 00840067101568: 302787-200
• 00840067101148: 302197-200
• 00840067101131: 302196-200
• 00840067101049: 302136-200
• 00840067101032: 302135-200
• 00840067100059: 302139-200