InfraVision 0220180517

GUDID 37613327061216

[Universal Ureteral Kit: 2 - Ureteral Catheters, 6 Fr Outer Diameter, 70 cm Length, 2 - Emitting Fiber, 0.75 Outer Diameter, 200 cm Length, Do not u

STRYKER CORPORATION

Ureteral catheter

• Primary Device ID: 37613327061216
• NIH Device Record Key: 29cf2765-ef9e-44fb-86f9-60ae8fef3905
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InfraVision
• Version Model Number: 0220180517
• Catalog Number: 0220180517
• 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	07613327061215 [Primary]
GS1	37613327061216 [Package]; Contains: 07613327061215; Package: pack [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061548

FDA Product Code

• FCS: Light, catheter, fiberoptic, glass, ureteral

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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