FDA.reportPublic FDA data

Skater™ Introducer System

Primary DI
00886333004539
Brand
Skater™ Introducer System
Company
ARGON MEDICAL DEVICES, INC.
Model
655506000
Catalog number
655506000
Device description
Skater™ Introducer System
Published
2022-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCBNeedle, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCBNeedle, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333004533PackageGS15In Commercial Distribution
00886333004539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300453320886333004533
00886333004539008863330045398863330045390886333004539

GMDN Terms#

Term, Definition table
TermDefinition
Non-vascular catheter introduction setA collection of invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
140727624
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886333210893Guidewire3951263951262016-09-21
00886333001408Skin Fix8025000008025000002022-07-14
00886333217618Skater™ Fix8025000018025000012022-07-14
00886333226320Co-Axial Introducer NeedleMCXS1620BXMCXS1620BX2022-07-21
00886333000005SKATER™ Drainage Catheter751106025E7511060252022-07-11
00886333000012SKATER™ Drainage Catheter751106035E7511060352022-07-12
00886333000029SKATER™ Drainage Catheter751107025E7511070252022-07-12
00886333000036SKATER™ Drainage Catheter751107035E7511070352022-07-11
00886333000043SKATER™ Drainage Catheter751108025E7511080252022-07-11
00886333000067SKATER™ Drainage Catheter751110025E7511100252022-07-12
00886333000074SKATER™ Drainage Catheter751110035E7511100352022-07-12
00886333000081SKATER™ Drainage Catheter751112025E7511120252022-07-13
00886333000098SKATER™ Drainage Catheter751112035E7511120352022-07-12
00886333000104SKATER™ Drainage Catheter751114025E7511140252022-07-12
00886333000111SKATER™ Drainage Catheter755106025E7551060252022-07-13
00886333000128SKATER™ Drainage Catheter755106035E7551060352022-07-12
00886333000135SKATER™ Drainage Catheter755107025E7551070252022-07-13
00886333000142SKATER™ Drainage Catheter755107035E7551070352022-07-12
00886333000159SKATER™ Drainage Catheter755108025E7551080252022-07-12
00886333000166SKATER™ Drainage Catheter 755108035E7551080352022-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068811084MONARCH™ Kit Catheter & AccessoriesAuris Health, Inc.GCB2026-05-05
10810068811060MONARCH™Guided Percutaneous Access KitAuris Health, Inc.GCB2026-05-04
00884450820667MAK-NV™Merit Medical Systems, Inc.GCB2026-02-24
00661392008960LSL HEALTHCARELSL Industries, LLCGCB2025-10-30
10841156111830TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111847TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111854TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111861TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111837TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111844TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111851TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111868TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
14026704920263PILLINGTELEFLEX INCORPORATEDGCB2024-07-15
14026704920270PILLINGTELEFLEX INCORPORATEDGCB2024-07-15
00884450820643MAK-NV™Merit Medical Systems, Inc.GCB2024-06-28
10884450820640MAK-NV™Merit Medical Systems, Inc.GCB2024-06-28
00884450820568MAK-NV™Merit Medical Systems, Inc.GCB2024-06-18
10884450820565MAK-NV™Merit Medical Systems, Inc.GCB2024-06-18
00884450820612MAK-NV™Merit Medical Systems, Inc.GCB2024-06-15
10884450820619MAK-NV™Merit Medical Systems, Inc.GCB2024-06-15
00884450820636MAK-NV™Merit Medical Systems, Inc.GCB2024-06-12
10884450820633MAK-NV™Merit Medical Systems, Inc.GCB2024-06-12
10381780538493MicroFrance®INTEGRA MICROFRANCEGCB2024-05-29
10841156110949TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110956TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110963TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110970TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
20841156110946TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
20841156110953TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
20841156110960TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08