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

• 37613327576802 - PELLO: 2024-11-21 4mm Angled 15 Degree Diamond Bur
• 37613327576826 - PELLO: 2024-11-21 4mm Angled 70 Degree Diamond Bur
• 07613327579031 - PELLO: 2024-11-21 4mm Angled 15 Degree Diamond Bur
• 07613327579055 - PELLO: 2024-11-21 4mm Angled 70 Degree Diamond Bur
• 07613327261820 - MAC: 2024-10-29 SCREWDRIVER
• 07613327271089 - DYNATRAN: 2024-10-29 COMPRESSOR
• 07613327273885 - Aero-LL: 2024-10-29 INSERTER - DISTRACTOR
• 37613327566162 - Neptune: 2024-10-23 V2 SPECIMEN COLLECTION MANIFOLD KIT