AccessGUDID - DEVICE: Nephro-Stent Nephroureteral Stent Catheter (H862NSL20828H0)

GUDID

Device Identifier (DI) Information

Brand Name: Nephro-Stent Nephroureteral Stent Catheter
Version or Model: NSL2-0828H
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NSL2-0828H
Company Name: URESIL, LLC

Primary DI Number: H862NSL20828H0
Issuing Agency: HIBCC
Commercial Distribution End Date: February 28, 2027
Device Count: 1
Labeler D-U-N-S® Number*: 192559557 *Terms of Use

Device Description: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 28 cm Pig-to-Pig

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJE	Catheter, Nephrostomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980889	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 8 French
Length: 28 Centimeter

Device Record Status

Public Device Record Key: 801d2f3e-dc09-4d32-a58b-917105432374
Public Version Date: May 02, 2022
Public Version Number: 5
DI Record Publish Date: September 06, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
H862NSL20828H2	4	H862NSL20828H1	2027-02-28	In Commercial Distribution	Shipper
H862NSL20828H1	5	H862NSL20828H0	2027-02-28	Not in Commercial Distribution	Dispenser