AccessGUDID - DEVICE: Nephro-Stent Nephroureteral Stent Catheter (H862NSL2T0822H0)

GUDID

Device Identifier (DI) Information

Brand Name: Nephro-Stent Nephroureteral Stent Catheter
Version or Model: NSL2T-0822H
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NSL2T-0822H
Company Name: URESIL, LLC

Primary DI Number: H862NSL2T0822H0
Issuing Agency: HIBCC
Commercial Distribution End Date: April 28, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 192559557 *Terms of Use

Device Description: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 22 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: 22 Centimeter

Device Record Status

Public Device Record Key: 4d26e7ef-1e10-4262-b811-5b8535cb3275
Public Version Date: April 29, 2022
Public Version Number: 2
DI Record Publish Date: June 09, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
H862NSL2T0822H1	5	H862NSL2T0822H0	2022-04-28	Not in Commercial Distribution	Dispenser
H862NSL2T0822H2	4	H862NSL2T0822H1	2022-04-28	Not in Commercial Distribution	Shipper