Posi-Stick® Guidewire PS2-18

GUDID 20841268108404

Posi-Stick® Guidewire

GALT MEDICAL CORP.

Peripheral vascular guidewire, manual
Primary Device ID20841268108404
NIH Device Record Keyd9c79adf-f397-4990-9a8b-91610bd15ff4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePosi-Stick® Guidewire
Version Model NumberSGW-068-00
Catalog NumberPS2-18
Company DUNS943156836
Company NameGALT MEDICAL CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
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

Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com

Device Dimensions

Outer Diameter0.018 Inch
Outer Diameter0.018 Inch
Outer Diameter0.018 Inch
Outer Diameter0.018 Inch
Outer Diameter0.018 Inch
Outer Diameter0.018 Inch
Outer Diameter0.018 Inch
Outer Diameter0.018 Inch
Outer Diameter0.018 Inch
Outer Diameter0.018 Inch
Outer Diameter0.018 Inch
Outer Diameter0.018 Inch
Outer Diameter0.018 Inch
Outer Diameter0.018 Inch
Outer Diameter0.018 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100841268108400 [Primary]
GS110841268108407 [Package]
Contains: 00841268108400
Package: Shelf box [10 Units]
In Commercial Distribution
GS120841268108404 [Package]
Contains: 10841268108407
Package: Shipper Box [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWire, Guide, Catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20841268108404]

Ethylene Oxide


[20841268108404]

Ethylene Oxide


[20841268108404]

Ethylene Oxide


[20841268108404]

Ethylene Oxide


[20841268108404]

Ethylene Oxide


[20841268108404]

Ethylene Oxide


[20841268108404]

Ethylene Oxide


[20841268108404]

Ethylene Oxide


[20841268108404]

Ethylene Oxide


[20841268108404]

Ethylene Oxide


[20841268108404]

Ethylene Oxide


[20841268108404]

Ethylene Oxide


[20841268108404]

Ethylene Oxide


[20841268108404]

Ethylene Oxide


[20841268108404]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-18
Device Publish Date2019-01-18

Devices Manufactured by GALT MEDICAL CORP.

10841268110134 - Guidewire2024-08-09 Guidewire
10841268109800 - Elite Transitionless Micro-Introducer Kit2022-08-23 Elite Transitionless Micro-Introducer Kit
10841268109817 - Elite Transitionless Micro-Introducer Kit2022-08-23 Elite Transitionless Micro-Introducer Kit
10841268109824 - Elite Transitionless Micro-Introducer Kit2022-08-23 Elite Transitionless Micro-Introducer Kit
10841268109831 - Elite Transitionless Micro-Introducer Kit2022-08-23 Elite Transitionless Micro-Introducer Kit
10841268109848 - Elite Transitionless Micro-Introducer Kit2022-08-23 Elite Transitionless Micro-Introducer Kit
10841268109855 - Elite Transitionless Micro-Introducer Kit2022-08-23 Elite Transitionless Micro-Introducer Kit
10841268109862 - Elite Transitionless Micro-Introducer Kit2022-08-23 Elite Transitionless Micro-Introducer Kit

Trademark Results [Posi-Stick]

Mark Image

Registration | Serial
Company
Trademark
Application Date
POSI-STICK
POSI-STICK
75089045 2072875 Live/Registered
URESIL, LLC
1996-04-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.