7.0FR (2.3mm) X 90 cm SINGLE J® URINARY DIVERSION URETERAL STENT

GUDID 00821925006072

intended to provide drainage of urine from the kidney to the outside stoma during the immediate postoperative period following any uretero-intestinal diversion procedure where the ureter is of sufficient size to allow easy passage of the stent.

Gyrus Acmi, Inc.

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• Primary Device ID: 00821925006072
• NIH Device Record Key: e2a1b2d0-f60f-4270-a135-4b2b35cff50d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 7.0FR (2.3mm) X 90 cm SINGLE J® URINARY DIVERSION URETERAL STENT
• Version Model Number: 5230600
• 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	00821925006072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800109

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.

• 00810008180983 - nCare: 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG
• 00810008180990 - nCare: 2023-10-02 nCare,D ,2 DRCT SDI, DICOM, RCRDG
• 00810008180501 - nCare: 2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg
• 00810008180921 - nCare: 2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
• 00810008180952 - nCare: 2023-09-25 nCare, SNGL,DRCT SDI,DICOM
• 00810008180969 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM
• 00810008180976 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
• 00821925036406 - USA Elite: 2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)