Cadwell Disposable Goggle Foam

GUDID 00840067102244

Disposable Goggle Foam, 10pk

CADWELL INDUSTRIES, INC.

Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph

• Primary Device ID: 00840067102244
• NIH Device Record Key: adacae62-65ff-44b1-8b7f-eed011af21e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cadwell Disposable Goggle Foam
• Version Model Number: 197278-000
• Company DUNS: 098554157
• Company Name: CADWELL INDUSTRIES, INC.
• Device Count: 10
• 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: true
• 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

Customer Support Contacts

• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com

Device Dimensions

• Length: 2.5 Inch
• Length: 2.5 Inch
• Length: 2.5 Inch
• Length: 2.5 Inch
• Length: 2.5 Inch
• Length: 2.5 Inch
• Length: 2.5 Inch
• Length: 2.5 Inch
• Length: 2.5 Inch
• Length: 2.5 Inch
• Length: 2.5 Inch
• Length: 2.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067102244 [Primary]
GS1	20840067102248 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162199

FDA Product Code

• OLT: Non-normalizing quantitative electroencephalograph software

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: 2017-07-11

Devices Manufactured by CADWELL INDUSTRIES, INC.

• 00840067102879 - Cadwell Guiardian: 2024-03-12 Power Comm
• 00840067102886 - Cadwell Guiardian: 2024-03-12 Base
• 00840067102893 - Cadwell Guiardian: 2024-03-12 24-Channel Omni Amplifier
• 00840067102909 - Cadwell Guiardian: 2024-03-12 ES-10 Electrical Stimulator
• 00840067102916 - Cadwell Guiardian: 2024-03-12 SMX-32 Direct Cortical Mapping
• 00840067103609 - Cadwell Guiardian: 2024-03-12 AVX Auditory and Visual Stimulator
• 10840067101411 - Cadwell Disposable Disc Electrodes: 2024-01-09
• 00840067103890 - Cadwell: 2022-10-03 Ring Electrode with 20in lead attached length