Aurora Condomcatheter Met Hydrocolloide Kleefzone

Aurora Condomcatheter Met Hydrocolloide Kleefzone
Aurora Hydrocolloide Adhesive Sheath - SU304

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.

No Data Available

• Outer Diameter: 36 Millimeter

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 10801741072045

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741072048

Package Quantity: 30

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA

Device Id: 00801741072048

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: 20801741072042

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10801741072045

Package Quantity: 180

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA