Posi-Stick Introducer Set PS2-1S

GUDID 10817640020506

Posi-Stick One-Step

URESIL, LLC

Fascial tissue dilator, single-use
Primary Device ID10817640020506
NIH Device Record Key404ab904-bed3-4df1-97f1-f3a7d8fd8c77
Commercial Distribution StatusIn Commercial Distribution
Brand NamePosi-Stick Introducer Set
Version Model NumberPS2-1S
Catalog NumberPS2-1S
Company DUNS192559557
Company NameURESIL, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817640020509 [Primary]
GS110817640020506 [Package]
Contains: 00817640020509
Package: Dispenser [5 Units]
In Commercial Distribution
GS120817640020503 [Package]
Package: Shipper [10 Units]
In Commercial Distribution
HIBCCH862PS21SNC0 [Previous]

FDA Product Code

KGZAccessories, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-13
Device Publish Date2022-06-03

On-Brand Devices [Posi-Stick Introducer Set]

H862PS21S2Posi-Stick One-Step
H862PS21SNC2Posi-Stick One-Step
H862PS238SW2Posi-Stick Intro. Set w/PT Marker & .038" Super-Stiff GW
H862PS2382Posi-Stick Intro. Set w/PT Marker & .038" & .018" GW
H862PS235SW2Posi-Stick Intro. Set w/PT Marker & .035" Super-Stiff GW
H862PS2352Posi-Stick Intro. Set w/PT Marker & .035" & .018" GW
H862PS2182Posi-Stick .018" (.046mm) Guidewire
H862PS2002Posi-Stick Introducer Set w/PT Marker
10817640020506Posi-Stick One-Step

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