350-195-004

GUDID 37613327061643

[Four Spike Irrigator Set, Non-pyrogenic fluid path, Do not use if package is damaged]

STRYKER CORPORATION

Surgical irrigation/aspiration tubing set

• Primary Device ID: 37613327061643
• NIH Device Record Key: 94a8e6c4-6139-42d3-95d9-8dc1c1a5304b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 0350195004
• Catalog Number: 350-195-004
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	07613327061642 [Primary]
GS1	37613327061643 [Package]; Contains: 07613327061642; Package: pack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000493

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-23

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• 07613327263015 - XIA II: 2025-07-17 CORONAL BENDER RIGHT
• 07613327661989 - KNOTILUS+: 2025-06-24 2.9X15.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
• 07613327661996 - KNOTILUS+: 2025-06-24 2.4X8.9MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE
• 07613327662009 - KNOTILUS+: 2025-06-24 2.4X11.3MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
• 07613327662016 - KNOTILUS+: 2025-06-24 2.9X12.5MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE
• 07613327662023 - KNOTILUS+: 2025-06-24 2.9X12.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
• 07613327662030 - ALPHAVENT: 2025-06-24 ALPHAVENT KNOTLESS SP, 4.75MM, BIOCOMPOSITE ANCHOR