Clear Advantage with Aloe Clear Silicone Self
Clear Advantage Male Continence Sheath - 2403NHS
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
- Store at room temperature
Device Sizes
- Outer Diameter: 40 Millimeter
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 IdentifiersDevice Id: 20801741070451
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10801741070454
Package Quantity: 100
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CA
Device Id: 10801741070454
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00801741070457
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CA
Device Id: 00801741070457
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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