FDA.reportPublic FDA data

Skater™ Nephrostomy Catheter

Primary DI
20886333001235
Brand
Skater™ Nephrostomy Catheter
Company
ARGON MEDICAL DEVICES, INC.
Model
755514035E
Catalog number
755514035
Device description
Skater™ Nephrostomy Catheter Non-Locking 14F x 35cm
Published
2022-07-12
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
GBOCatheter, Nephrostomy, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBOCatheter, Nephrostomy, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333001235PackageGS15In Commercial Distribution
00886333001231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300123520886333001235
00886333001231008863330012318863330012310886333001231

GMDN Terms#

Term, Definition table
TermDefinition
Nephrostomy catheterA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20886333227864V-Stick Vascular Access Set391504300E391504300E2026-03-20
20886333227871V-Stick Vascular Access Set391505300E391505300E2026-03-20
20886333227888V-Stick Vascular Access Set 391505400E391505400E2026-03-20
20886333227895V-Stick Vascular Access Set391604300E391604300E2026-03-20
20886333227901V-Stick Vascular Access Set 391605300E391605300E2026-03-20
20886333227918V- Stick Vascular Access Set391605400E391605400E2026-03-20
20886333227925V-Stick Vascular Access Set391504400E391504400E2026-03-20
20886333227932V-Stick Vascular Access Set391604400E391604400E2026-03-20
20886333209259Tumescent Infiltration Kit1981431981432025-05-02
10886333227584OneStic Micro-Access Introducer4978864978862025-05-02
20886333227116Bone Access NeedleDBANJ0806TLDBANJ0806TL2023-01-03
20886333227659Transfermoral Transcaval Liver Biopsy SystemTF-18CTF-18C2024-08-12
20886333227499ClosureFast GuidewireGW-025-260-1.5JGW-025-260-1.5J2024-07-29
20886333227505ClosureFast GuidewireGW-035-45GW-035-452024-07-29
20886333227512ClosureFast Introducer Sheath IS-7F07IS-7F072024-07-29
20886333227529ClosureFast Introducer Sheath IS-7F11IS-7F112024-07-29
20886333227550ClosureFast Micro Puncture MPK-4FMPK-4F2024-07-29
20886333227567ClosureFast Micro PunctureMPK-5FMPK-5F2024-07-29
20886333227574ClosureFast Tumescent Infiltration KitTIK-01TIK-012024-07-29
20886333227444ClosureFast Arterial NeedleAN-19GEAN-19GE2024-07-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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25051684011621Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011638Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011645Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011652Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011669Total AbscessionAngiodynamics, Inc.GBO2024-10-30
04046955638406ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638581ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638604ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638741ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638789ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638840ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638888ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638963ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638987ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639007ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639021ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639045ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639083ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639106ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639120ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639144ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639182ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639205ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
10812261012282allDrainALLWIN MEDICAL DEVICES, INC.GBO2023-07-28
16936881156561Nephrostomy introduction Needle Diamond TipWell Lead Medical Co.,LtdGBO2022-12-08
16936881156578Nephrostomy introduction Needle Diamond TipWell Lead Medical Co.,LtdGBO2022-12-08