8.5FR (2.81mm) X 26 cm Double Pigtail URETERAL STENT HYDROPHILIC COATED TECOF

GUDID 00821925003514

serving as a temporary indwelling catheter.

Gyrus Acmi, Inc.

Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent

• Primary Device ID: 00821925003514
• NIH Device Record Key: c6b6abbb-bce6-4926-8ec0-6f9eed548cb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8.5FR (2.81mm) X 26 cm Double Pigtail URETERAL STENT HYDROPHILIC COATED TECOF
• Version Model Number: 5608526
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925003514 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• 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

Devices Manufactured by Gyrus Acmi, Inc.

• 00821925041394 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 0, UNI. LIGHT INSTACLEAR
• 00821925041400 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 30DEG, TOP LIGHT INSTACLEAR
• 00821925041417 - InstaClear: 2024-04-30 SHEATH LENS CLEANER ULTRA 30DEG, BOTTOM LIGHT INSTACLEAR
• 00821925041424 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, TOP LIGHT INSTACLEAR
• 00821925041431 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, BOTTOM LIGHT INSTACLEAR
• 00821925041448 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER UNLTRA 70DEG, TOP LIGHT INSTACLEAR
• 00821925041455 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 70DEG, BOTTOM LIGHT INSTACLEAR
• 00810008180983 - nCare: 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG