IRIS 0220180518

GUDID 37613327174817

[Ureteral Kit: 2 - Ureteral Catheters, 6 Fr Outer Diameter, 70 cm Length, 2 - Emitting Fiber, 0.75 Outer Diameter, 370 cm Length, Do not use if pack

STRYKER CORPORATION

Ureteral transilluminator, single-use

• Primary Device ID: 37613327174817
• NIH Device Record Key: 6444a0fd-a4dd-43dc-bb3c-25679bb7c6d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRIS
• Version Model Number: 0220180518
• Catalog Number: 0220180518
• 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	07613327174816 [Primary]
GS1	37613327174817 [Package]; Contains: 07613327174816; Package: pack [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151243

FDA Product Code

• FCW: Light source, fiberoptic, routine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-23

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• 07613327631890 - OptaBlate: 2025-04-25 Straight 10MM Probe Single Kit
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• 07613327626407 - ThermaClear: 2025-04-14
• 07613327626469 - ThermaClear: 2025-04-14