FDA.reportPublic FDA data

Nephro-Stent Nephroureteral Stent Catheter

Primary DI
10817640020407
Brand
Nephro-Stent Nephroureteral Stent Catheter
Company
URESIL, LLC
Model
NSL2-0826H
Catalog number
NSL2-0826H
Device description
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 26 cm Pig-to-Pig
Published
2022-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJECatheter, Nephrostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJECatheter, NephrostomyUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980889000URESIL NEPHRO-URETERAL STENTUresil Corp.1998-04-08LJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817640020407PackageGS15In Commercial Distribution
20817640020404PackageGS14In Commercial Distribution
H862NSL20826H0PreviousHIBCC0
00817640020400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081764002040710817640020407
2081764002040420817640020404
00817640020400008176400204008176400204000817640020400

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French
Length26Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-538-7374sales@uresil.com

Regulatory Flags#

DUNS number
192559557
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H862TIVCNC0Tru-Incise Valvulotome with Interchangeable HeadsTIVCTIVC2019-09-17
H862TIVH20NC0Tru-Incise Valvulotome with Interchangeable HeadsTIVH20TIVH202019-09-17
H862TIVH30NC0Tru-Incise Valvulotome with Interchangeable HeadsTIVH30TIVH302019-09-17
H862TIVH40NC0Tru-Incise Valvulotome with Interchangeable HeadsTIVH40TIVH402019-09-11
H862TIVK2030NC0Tru-Incise Valvulotome with Interchangeable HeadsTIVK2030TIVK20302019-09-11
H862TC6000Gravity Drainage BagTC600TC6002017-09-11
00817640020486Ulti-Flo General Purpose Drainage CatheterLBL2T-1430HBLBL2T-1430HB2022-04-27
00817640020493Ulti-Flo General Purpose Drainage CatheterLBL2T-1630HBLBL2T-1630HB2022-04-27
00817640020998GP General Purpose Drainage CatheterMPL2T-0625HMPL2T-0625H2022-04-27
00817640021339Ulti-Flo General Purpose Drainage CatheterLBL2-1430HBLBL2-1430HB2022-04-28
00817640021346Ulti-Flo General Purpose Drainage CatheterLBL2-1630HBLBL2-1630HB2022-04-28
00817640021643GP General Purpose Drainage CatheterGPL2T-0625HGPL2T-0625H2022-04-27
00817640020165Nephro-Stent Nephroureteral Stent CatheterNSL2T-0822HNSL2T-0822H2022-04-28
00817640020172Nephro-Stent Nephroureteral Stent CatheterNSL2T-0824HNSL2T-0824H2022-04-28
00817640020189Nephro-Stent Nephroureteral Stent CatheterNSL2T-0826HNSL2T-0826H2022-04-28
00817640020196Nephro-Stent Nephroureteral Stent CatheterNSL2T-0828HNSL2T-0828H2022-04-28
00817640020516Nephro-Stent Nephroureteral Stent CatheterNSL2T-1022HNSL2T-1022H2022-04-28
00817640020523Nephro-Stent Nephroureteral Stent CatheterNSL2T-1024HNSL2T-1024H2022-04-28
00817640020530Nephro-Stent Nephroureteral Stent CatheterNSL2T-1026HNSL2T-1026H2022-04-28
00817640020547Nephro-Stent Nephroureteral Stent CatheterNSL2T-1028HNSL2T-1028H2022-04-28

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05701780271080KolibriColoplast A/SLJE2023-01-20
05701780271110KolibriColoplast A/SLJE2023-01-20
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05701780271202KolibriColoplast A/SLJE2023-01-20
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05701780271295KolibriColoplast A/SLJE2023-01-20
05701780271325KolibriColoplast A/SLJE2023-01-20
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05701780271561KolibriColoplast A/SLJE2023-01-20
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