SwitchPoint Infinity, iSuite 0678-003-000

GUDID 07613327054255

Infinity 3, Lite Video Router

STRYKER COMMUNICATIONS INC.

Operating room audiovisual data/device management system

• Primary Device ID: 07613327054255
• NIH Device Record Key: 93ed347a-9b73-4560-8338-d14f745ad033
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SwitchPoint Infinity, iSuite
• Version Model Number: 0678003000
• Catalog Number: 0678-003-000
• Company DUNS: 078807493
• Company Name: STRYKER COMMUNICATIONS INC.
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)726-3705
• Email: SCC-CS2@stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327054255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100852

FDA Product Code

• OCS: Endoscopic video imaging system/component, gastroenterology-urology

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: 2016-09-23

On-Brand Devices [SwitchPoint Infinity, iSuite]

• 07613327054255: Infinity 3, Lite Video Router
• 07613327054156: Infinity 3, Video Router