- Physicians Office Resource

Totalis™ Rigid Endo Kit with InLay® VersaFit™ Ureteral Stent, EcoFlex™ Stone Basket and NiCore® Nitinol Guidewire
Totalis™ Rigid Endo Kit - REK32N

Device Description

A collection of devices intended to assist treatment of a blocked ureter and to help maintain ureteral patency through natural orifice or percutaneous access. It includes a polymeric ureteral stent, a device(s) intended to trap, retrieve, and/or manipulate urinary stones (e.g., urinary stone retrieval basket), and typically devices associated with access/stent-implantation (e.g., guidewire). This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

Catheter Gauge: 6 French

Catheter Gauge: 6 French

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: FAD

Device Name: Stent, Ureteral

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 876.4620

Third Party Flag: Y

Medical Specialty: GU

Device Identifiers

Device Id: 10801741097598

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741097591

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA

Device Id: 00801741097591

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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