- Physicians Office Resource

SureStep Male External Catheter System Starter Kit with 2000ml Urine Collection Bag
SureStep Male External Catheter System - MECSB010

Device Description

A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: NNX

Device Name: Device, Incontinence, Urosheath Type, Non-Sterile

Device Class: 1

Physical State: N/A

Definition: Urine collector and accessories; see product code EXJ

Submission Type ID: 4

Review Panel: GU

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.5250

Third Party Flag: N

Medical Specialty: GU

Device Identifiers

Device Id: 10801741183628

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741183621

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA

Device Id: 00801741183621

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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