BARDEX SUTURE STENT W/HYDROGLIDE

BARDEX SUTURE STENT W/HYDROGLIDE
Bardex® Soft Double Pigtail Ureteral Stent with Suture - 090826SL

A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.

No Data Available

• Length: 26 Centimeter
• Catheter Gauge: 8 French

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FAD

Device Name: Stent, Ureteral

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: Y

Target Area: N/A

Regulation Number: 876.4620

Third Party Flag: Y

Medical Specialty: GU

Device Id: 00801741016134

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