UroPass Ureteral Access Sheath

GUDID 00821925035294

Gyrus Acmi, Inc.

Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter 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