AccessGUDID - DEVICE: Nephro-Cath Nephrostomy Drainage Catheter (H862NCL2T1235H0)

GUDID

Device Identifier (DI) Information

Brand Name: Nephro-Cath Nephrostomy Drainage Catheter
Version or Model: NCL2T-1235H
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NCL2T-1235H
Company Name: URESIL, LLC

Primary DI Number: H862NCL2T1235H0
Issuing Agency: HIBCC
Commercial Distribution End Date: April 27, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 192559557 *Terms of Use

Device Description: HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, 12F

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
GBO	Catheter, Nephrostomy, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 12 French
Length: 27 Centimeter

Device Record Status

Public Device Record Key: d03e2e96-824a-4664-ad99-52e2ea90f995
Public Version Date: April 28, 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
H862NCL2T1235H1	5	H862NCL2T1235H0	2022-04-27	Not in Commercial Distribution	Dispenser
H862NCL2T1235H2	4	H862NCL2T1235H1	2022-04-27	Not in Commercial Distribution	Shipper