FDA.reportPublic FDA data

Posi-Stick Introducer Set

Primary DI
H862PS2000
Brand
Posi-Stick Introducer Set
Company
URESIL, LLC
Model
PS2-00
Catalog number
PS2-00
Device description
Posi-Stick Introducer Set w/PT Marker
Published
2016-08-29
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H862PS2001PackageHIBCC10Not in Commercial Distribution
H862PS2002PackageHIBCC1Not in Commercial Distribution
H862PS2000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fascial tissue dilator, single-useA surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose, inflatable balloon or screw-tip at its distal end, that is available in a variety of sizes and typically made of metal or plastic. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
192559557
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817640020462Thora-Vent Thoracic VentOTW11-13OTW11-132022-06-02
H862TFK060Tru-Fix Catheter Fixation KitTFK-06TFK-062016-08-31
H862TFK080Tru-Fix Catheter Fixation KitTFK-08TFK-082016-08-31
H862TFK100Tru-Fix Catheter Fixation KitTFK-10TFK-102016-08-31
H862TFK120Tru-Fix Catheter Fixation KitTFK-12TFK-122016-08-31
H862TFK140Tru-Fix Catheter Fixation KitTFK-14TFK-142016-08-31
H862TFK160Tru-Fix Catheter Fixation KitTFK-16TFK-162016-08-31
H862TVST0Thora-Vent Thoracic VentTVSTTVST2016-09-07
H862TC600L0Gravity Drainage BagTC600LTC600L2017-09-11
H862TFDR0Tru-Fix Catheter Fixation KitTFD-RTFD-R2016-08-31
00817640020639Tru-Fix Catheter Fixation KitTFD-RTFD-R2022-05-12
00817640020646Tru-Fix Catheter Fixation KitTFK-06TFK-062022-05-12
00817640020653Tru-Fix Catheter Fixation KitTFK-08TFK-082022-05-12
00817640020660Tru-Fix Catheter Fixation KitTFK-10TFK-102022-05-12
00817640020677Tru-Fix Catheter Fixation KitTFK-12TFK-122022-05-12
00817640020684Tru-Fix Catheter Fixation KitTFK-14TFK-142022-05-12
00817640020691Tru-Fix Catheter Fixation KitTFK-16TFK-162022-05-12
H862DFALL0Aspiration and Flush AssemblyDFA-LLDFA-LL2016-08-29
H862TV11100Thora-Vent Thoracic VentTV11-10TV11-102016-09-07
H862TV11130Thora-Vent Thoracic VentTV11-13TV11-132016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
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10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
08498840011300VYGONVygon CorporationDYB2019-04-08
08498840011317VYGONVygon CorporationDYB2019-04-08
08498840011751VYGONVygon CorporationDYB2019-04-08
08498840011768VYGONVygon CorporationDYB2019-04-08
08498840011775VYGONVygon CorporationDYB2019-04-08
08498840011782VYGONVygon CorporationDYB2019-04-08
08498840011799VYGONVygon CorporationDYB2019-04-08
08498840011805VYGONVygon CorporationDYB2019-04-08
08498840011812VYGONVygon CorporationDYB2019-04-08
08498840012215VYGONVygon CorporationDYB2019-04-08
H965481030ENVINAVILYST MEDICAL, INC.DYB2019-01-03
07613327459210AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDYB2018-10-26
00813502010664Introducer Kit for Impella®Oscor Inc.DYB2017-11-30
00813502010237Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010244Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010558Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
H965481080NavylistNAVILYST MEDICAL, INC.DYB2017-08-07
H965355010ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355020ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355030ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355060ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355080ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355090ENVINAVILYST MEDICAL, INC.DYB2017-08-07