Sierra Summit

GUDID 00840067100103

Sierra Summit 2 Ch. Amplifier

CADWELL INDUSTRIES, INC.

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• Primary Device ID: 00840067100103
• NIH Device Record Key: de15ab7d-63c5-4ac9-b203-bdbd7a4cdd9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sierra Summit
• Version Model Number: 190276-200
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840067100103 [Primary]

FDA Product Code

• GWQ: Full-montage Standard Electroencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-15
• Device Publish Date: 2016-09-05

On-Brand Devices [Sierra Summit]

• 00840067100103: Sierra Summit 2 Ch. Amplifier
• 00840067100325: Sierra Summit Bone Vibrator
• 00840067100301: Sierra Summit Remote Input Box
• 00840067100288: VEP Cal Sensor
• 00840067100264: RING/BAR ELECTRODE SWITCH BOX
• 00840067100097: Sierra Summit 12 Ch. Amplifier
• 00840067100035: Sierra Summit Base
• 00840067100011: Sierra Summit StimTroller Plus
• 00840067102848: SUMMIT ER-3C INSERT EARPHONE CABLE