FDA.reportPublic FDA data

Scorpion

Primary DI
00886333225552
Brand
Scorpion
Company
ARGON MEDICAL DEVICES, INC.
Model
TPS005
Catalog number
TPS005
Device description
Scorpion® - Portal Vein Access Set
Published
2021-02-24
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202141000Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access SetArgon Medical Devices, Inc.2021-01-15DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886333225552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886333225552008863332255528863332255520886333225552

GMDN Terms#

Term, Definition table
TermDefinition
Portosystemic needle setA collection of sterile devices which includes a portosystemic needle intended to create an artificial passage between the hepatic and portal veins (through the liver parenchyma) as part of a transjugular intrahepatic portosystemic shunt (TIPS) procedure. It includes a rigid metal portosystemic needle, a vascular guide catheter, and might include the initial percutaneous vascular introduction devices (e.g., sheath, dilator); neither a balloon catheter nor a shunt is included. This is a single-use device.

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
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
10801902226416ARROWTELEFLEX INCORPORATEDDYB2026-08-03
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DYB2026-07-31
06974949033792CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-30
06974949033808CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-30
10801902193114ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193121ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193190ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193206ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196184ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196498ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196511ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196528ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902200768ARROWTELEFLEX INCORPORATEDDYB2026-07-30
06974949033785CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-29
10801902196412ARROWTELEFLEX INCORPORATEDDYB2026-07-29
20801902193470ARROWTELEFLEX INCORPORATEDDYB2026-07-29
10801902189872ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902196436ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902198850ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902226409ARROWTELEFLEX INCORPORATEDDYB2026-07-27
10801902226485ARROWTELEFLEX INCORPORATEDDYB2026-07-22
00850064198676Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
00850064198683Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
10884450119799Prelude EASE™Merit Medical Systems, Inc.DYB2026-06-09
10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
04251244502768Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDYB2024-08-19