Statlock Catheter Stabilization Device


Product Overview

Statlock Catheter Stabilization Device
StatLock Urological - STATURO25


Device Description

A device designed to be attached to a patient's body to hold an indwelling urinary catheter line (e.g., Foley) in place. It consists of a wrap or adhesive strip/pad placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook, loop, clip) without creating excessive pressure on it and permitting visual inspection of the site. It is not designed to hold a urine collection bag. 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: 10801741215909

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741215902

Package Quantity: 20

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA


Device Id: 00801741215902

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


Device Id: 20801741215906

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10801741215909

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BX


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