SDC3 0240060100

GUDID 07613327056150

HD Information Management System

STRYKER CORPORATION

Operating room audiovisual data/device management system

• Primary Device ID: 07613327056150
• NIH Device Record Key: d61c8573-4526-42d0-ae88-db51683f669a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SDC3
• Version Model Number: 0240060100
• Catalog Number: 0240060100
• Company DUNS: 187502109
• Company Name: STRYKER CORPORATION
• 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)624-4422
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327056150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160332

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

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 [SDC3]

• 07613327056174: Device Control Package
• 07613327056167: Voice Control Package
• 07613327056150: HD Information Management System