SDC4K 0240300100

GUDID 07613327562750

Information Management System

STRYKER CORPORATION

Operating room audiovisual data/device management system

• Primary Device ID: 07613327562750
• NIH Device Record Key: 8456ade8-1b8e-4f84-aaea-a7feeccb75a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SDC4K
• Version Model Number: 0240300100
• Catalog Number: 0240300100
• 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
• 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	07613327562750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220108

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: 2022-04-12
• Device Publish Date: 2022-04-04

Devices Manufactured by STRYKER CORPORATION

• 07613327508437 - Tritanium X: 2024-09-16 TL Expandable Curved Posterior Lumbar Cage
• 07613327006933 - ES2 SPINAL SYSTEM: 2024-09-11 BLOCKER INSERTER
• 07613327006964 - ES2 SPINAL SYSTEM: 2024-09-11 ROD INSERTER
• 07613327006995 - ES2 SPINAL SYSTEM: 2024-09-11 RECOVERY GUIDE
• 07613327007008 - ES2 SPINAL SYSTEM: 2024-09-11 INNER SHAFT, RECOVERY SYSTEM
• 07613327007022 - ES2 SPINAL SYSTEM: 2024-09-11 THREADED RECOVERY GUIDE
• 07613327007046 - ES2 SPINAL SYSTEM: 2024-09-11 ROD INSERTER
• 07613327114867 - XIA 4.5 EVOLUTION: 2024-09-11 BLOCKER INSERTER