Nephro-Cath Nephrostomy Drainage Catheter - HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER - URESIL, LLC

Duns Number:192559557

Device Description: HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, LONG, 14F

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More Product Details

Catalog Number

NCL2T-1450HB

Brand Name

Nephro-Cath Nephrostomy Drainage Catheter

Version/Model Number

NCL2T-1450HB

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 27, 2022

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GBO

Product Code Name

Catheter, Nephrostomy, General & Plastic Surgery

Device Record Status

Public Device Record Key

67e448d1-32d6-40e6-8afc-d3e499d74230

Public Version Date

April 28, 2022

Public Version Number

2

DI Record Publish Date

June 09, 2021

Additional Identifiers

Package DI Number

H862NCL2T1450HB1

Quantity per Package

5

Contains DI Package

H862NCL2T1450HB0

Package Discontinue Date

April 27, 2022

Package Status

Not in Commercial Distribution

Package Type

Dispenser

"URESIL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 179
2 A medical device with a moderate to high risk that requires special controls. 77
U Unclassified 24