Nephro-Cath Nephrostomy Drainage Catheter

Basic Information

• Brand Name: Nephro-Cath Nephrostomy Drainage Catheter
• Primary DI: H862NCP0835HB0
• Version / Model: NCP-0835HB
• Catalog Number: NCP-0835HB
• Company Name: URESIL, LLC
• Labeler DUNS: 192559557
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-06
• Public Version: 3
• Public Version Date: 2019-01-28
• Public Version Status: Update
• Public Device Record Key: 3c60580a-a3a7-42e0-bb45-2d7361d35aaa
• Distribution End Date: 2018-04-25

Device Description

Nephrostomy "HB" Catheter - Non-Locking - 8F 35

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10735	Nephrostomy catheter	A sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H862NCP0835HB2	HIBCC	Shipper	4	Not in Commercial Distribution	2018-04-25
Package	H862NCP0835HB1	HIBCC	Dispenser	5	Not in Commercial Distribution	2018-04-25
Primary	H862NCP0835HB0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	8	French
Length	29	Centimeter