DEVICE: Nephro-Cath Nephrostomy Drainage Catheter (H862NCL20835HBK0)
Device Identifier (DI) Information
Nephro-Cath Nephrostomy Drainage Catheter
NCL2-0835HB-K
In Commercial Distribution
NCL2-0835HB-K
URESIL, LLC
NCL2-0835HB-K
In Commercial Distribution
NCL2-0835HB-K
URESIL, LLC
HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER KIT WITH DEPTH MARKS, 8F
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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GBO | Catheter, Nephrostomy, General & Plastic Surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Catheter Gauge: 8 French |
Length: 28 Centimeter |
Device Record Status
caf3bbc8-30a5-41af-a4ef-6472a11d3d03
June 08, 2021
5
September 05, 2016
June 08, 2021
5
September 05, 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 |
---|---|---|---|---|---|
H862NCL20835HBK2 | 5 | H862NCL20835HBK0 | 2024-12-31 | In Commercial Distribution | Shipper |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-538-7374
sales@uresil.com
sales@uresil.com