- Physicians Office Resource

Bardex® Heyman Nephrostomy Short Tip Councill Model Hollow Stylet for use with Bard® Nephrostomy Short Tip Councill Catheters
Bardex® Heyman Nephrostomy Short Tip Councill Model Hollow Stylet - 190500

Device Description

A hand-held manual surgical instrument designed with a sharp pyramidal or conical point at the distal end to percutaneously puncture the lower abdominal wall to provide suprapubic access for surgical repair, typically to position a sling used in the treatment of female stress urinary incontinence (SUI) associated with a bladder prolapse. The needle is typically made of a high-grade stainless steel rod (curved or malleable) with a pointed tip and an eye or notch at the distal end to help position the sling. This device can be made of metal and/or synthetic materials. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

Catheter Gauge: 6 French

Catheter Gauge: 6 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

Code: QGC

Device Name: Suprapubic Catheter Accessories

Device Class: 1

Physical State: Introducer, access dilator, and peel-away sheath

Definition: Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath.

Submission Type ID: 4

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The accessories are used to aid in placement of suprapubic catheters.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Bladder, pubic tissue

Regulation Number: 876.5100

Third Party Flag: N

Medical Specialty: GU

Device Identifiers

Device Id: 10801741030380

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741030383

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA

Device Id: 00801741030383

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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