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Nephro-Stent Nephroureteral Stent Catheter

FDA UDI

Class U (US FDA UDI)

by Uresil Corp.

Identity

Trade Name
Nephro-Stent Nephroureteral Stent Catheter FDA UDI
Generic Name
Nephrostomy catheter FDA UDI
Device Name
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 26 cm Pig-to-Pig FDA UDI
Model / Reference
NSL2T-0826H FDA UDI
Description
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 26 cm Pig-to-Pig FDA UDI

Identifiers

Catalog Number
NSL2T-0826H FDA UDI
Primary DI / UDI-DI
H862NSL2T0826H0 FDA UDI
510(k) Number
K980889 FDA UDI
FDA Product Code
LJE FDA UDI
GMDN Term
Nephrostomy catheter FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 8 French FDA UDI
Length — 26 Centimeter FDA UDI

Nephro-Stent Nephroureteral Stent Catheter by Uresil Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K980889 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Uresil Corp.

Sources (1)

  • FDA UDI 712f1aba-f1ea-4ea1-bbc8-7f2ae75904b1 38 fields · synced May 30, 2026