Nephro-EZDilate KIT 30Fr (10mm) x 15cm URETERAL BALLOON DILATION CATH

GUDID 00821925033030

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: 00821925033030
• NIH Device Record Key: 54dfb0c8-2be9-4699-8ce8-5426597c76ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nephro-EZDilate KIT 30Fr (10mm) x 15cm URETERAL BALLOON DILATION CATH
• Version Model Number: BPCN1015K
• 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	00821925033030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132383

FDA Product Code

• LJE: CATHETER, NEPHROSTOMY

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: 2017-05-11

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)