UroPass Ureteral Access Sheath

GUDID 00821925035294

Gyrus Acmi, Inc.

Ureteral catheter

• Primary Device ID: 00821925035294
• NIH Device Record Key: 111ee23c-b67e-4e56-a1b6-a01a05dfc016
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UroPass Ureteral Access Sheath
• Version Model Number: 61346BX
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925035294 [Package]; Contains: 00821925035454; Package: [5 Units]; In Commercial Distribution
GS1	00821925035454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051593

FDA Product Code

• KNY: ACCESSORIES, CATHETER, G-U

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-03

On-Brand Devices [UroPass Ureteral Access Sheath]

• 00821925035300: 61354BX
• 00821925035294: 61346BX
• 00821925035287: 61338BX
• 00821925035270: 61324BX
• 00821925005990: 61254BX
• 00821925035256: 61246BX
• 00821925005983: 61238BX
• 00821925005976: 61224BX
• 00821925035225: 61154BX
• 00821925035218: 61146BX
• 00821925035201: 61138BX
• 00821925035195: 61124BX
• 00821925035188: 61054BX
• 00821925035171: 61046BX
• 00821925035164: 61038BX
• 00821925035157: 61024BX