UROPASS II, 6.0 X 26 CM WO/GW

GUDID 00821925001084

Gyrus Acmi, Inc.

Polymeric ureteral stent

• Primary Device ID: 00821925001084
• NIH Device Record Key: 7880ee50-5dff-4b58-b045-05e1c283924c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UROPASS II, 6.0 X 26 CM WO/GW
• Version Model Number: 5436026
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925001084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K832915

FDA Product Code

• FAD: STENT, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-03

Devices Manufactured by Gyrus Acmi, Inc.

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• 00821925002111 - USA Elite System: 2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Coded Gold