Engage Medical Device Alert Notification System (EMDAN) 910-01947

GUDID 00860002177779

STRYKER CORPORATION

Alarm application software

• Primary Device ID: 00860002177779
• NIH Device Record Key: b5046ff1-4945-4b6a-856e-adfd44beb740
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Engage Medical Device Alert Notification System (EMDAN)
• Version Model Number: 910-01947
• Catalog Number: 910-01947
• Company DUNS: 078470558
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002177779 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130339

FDA Product Code

• MSX: System, network and communication, physiological monitors

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: 2022-08-26
• Device Publish Date: 2022-08-18

Devices Manufactured by STRYKER CORPORATION

• 07613327261844 - O.I.C. TITANIUM: 2026-02-09 CAGE IMPACTOR
• 07613327261868 - O.I.C. TITANIUM: 2026-02-09 FINAL CAGE IMPACTOR
• 07613327264722 - XIA 4.5: 2026-02-09 HOOK IMPACTOR
• 07613327264753 - XIA 4.5: 2026-02-09 DUAL STAPLE IMPACTOR
• 07613327265460 - XIA 3: 2026-02-09 HOOK IMPACTOR
• 07613327267037 - VLIFT: 2026-02-09 ENDCAP IMPACTOR
• 07613327267068 - VLIFT: 2026-02-09 ENDCAP IMPACTOR
• 07613327267563 - AVS: 2026-02-09 AS SPACER IMPACTOR STRAIGHT