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

Devices Manufactured by STRYKER CORPORATION

• 07613327419252 - Patient Helper: 2024-12-23
• 37613327556651 - Neptune: 2024-12-23 SafeAir 125mm Suction Sleeve, Non-Sterile
• 07613327643879 - Iconix: 2024-12-19 Iconix DC Guide for 2.3mm Anchor
• 07613327643886 - Iconix: 2024-12-19 Iconix DC Obturator for 2.3 Anchor
• 07613327644067 - Neptune: 2024-12-16 V2 SPECIMEN COLLECTION MANIFOLD
• 07613327262469 - VBOSS: 2024-12-10 ENDPLATE TIP SMALL
• 07613327262483 - VBOSS: 2024-12-10 ENDPLATE TIP LARGE
• 07613327262506 - VBOSS: 2024-12-10 ENDPLATE TIP OFFSET