Uro-EZDilate 15Fr (5mm) x 10cm

GUDID 00821925033108

Gyrus Acmi, Inc.

Ureteral dilatation catheter Ureteral dilatation catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter

• Primary Device ID: 00821925033108
• NIH Device Record Key: f6133736-ede6-47d8-be10-5c51ef343ab7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uro-EZDilate 15Fr (5mm) x 10cm
• Version Model Number: BURS0510
• 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	00821925033108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132181

FDA Product Code

• KOE: DILATOR, URETHRAL

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: 2016-10-05

Devices Manufactured by Gyrus Acmi, Inc.

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• 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)