SDC4K Information Management System 0240-300-200

GUDID 07613327601701

STRYKER CORPORATION

Operating room audiovisual data/device management system

• Primary Device ID: 07613327601701
• NIH Device Record Key: a9d69b0b-889f-48dc-9579-196be90aff73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SDC4K Information Management System
• Version Model Number: 0240300200
• Catalog Number: 0240-300-200
• 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
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327601701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241401

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-12
• Device Publish Date: 2025-06-04

Devices Manufactured by STRYKER CORPORATION

• 07613327601695 - Connected OR Hub: 2025-06-12
• 07613327601701 - SDC4K Information Management System: 2025-06-12
• 07613327601701 - SDC4K Information Management System: 2025-06-12
• 07613327482706 - N/A: 2025-05-08 System 9 Transfer Shield, Small
• 07613327163278 - NA: 2025-04-28
• 07613327601138 - OptaBlate: 2025-04-25 Curve 10mm Probe Single Kit
• 07613327601145 - OptaBlate: 2025-04-25 Curve 20mm Probe Single Kit
• 07613327601152 - OptaBlate: 2025-04-25 Curve 15mm Probe Single Kit
• 07613327631883 - OptaBlate: 2025-04-25 Straight 10MM Probe Dual Kit