8.5FR (2.81mm) X 20 cm Double Pigtail URETERAL STENT HYDROPHILIC COATED TECOF

GUDID 00821925003989

serving as a temporary indwelling catheter.

Gyrus Acmi, Inc.

Polymeric ureteral stent

• Primary Device ID: 00821925003989
• NIH Device Record Key: cc7b4dbc-3507-4eda-8032-84888ae30c8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8.5FR (2.81mm) X 20 cm Double Pigtail URETERAL STENT HYDROPHILIC COATED TECOF
• Version Model Number: 5608520
• 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

Customer Support Contacts

• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx
• Phone: 18885247266
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925003989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905289
• Premarket Notification: K960148

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: 2015-10-24

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• 00821925002098 - USA Elite System: 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
• 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