Magic3™ Intermittent Catheter with Sure
Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve - 53616G
Device Description
A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Catheter Gauge: 16 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KOD
Device Name: Catheter, Urological
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: N
Target Area: N/A
Regulation Number: 876.5130
Third Party Flag: Y
Medical Specialty: GU
Device IdentifiersDevice Id: 10801741069786
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00801741069789
Package Quantity: 30
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CA
Device Id: 00801741069789
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: 20801741069783
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10801741069786
Package Quantity: 180
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CA