Spex LP

GUDID 00850025525015

speX LP Shapeable Support Catheter, 35 X 90cm, US

REFLOW MEDICAL, INC.

Vascular guide-catheter, single-use
Primary Device ID00850025525015
NIH Device Record Key974148dd-e536-4810-8c9b-6c1b1b7c81d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpex LP
Version Model NumberSLP35090US
Company DUNS962545294
Company NameREFLOW MEDICAL, INC.
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com
Phone9494810399
Emailquality@reflowmedical.com

Device Dimensions

Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length90 Centimeter
Guidewire Diameter0.035 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100850025525015 [Primary]
GS110850025525012 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-18
Device Publish Date2021-06-10

On-Brand Devices [Spex LP]

00856492005685speX LP Shapeable Support Catheter, 18 X 150cm, US
00856492005678speX LP Shapeable Support Catheter, 18 X 135cm, US
00856492005661speX LP Shapeable Support Catheter, 18 X 90cm, US
00856492005654speX LP Shapeable Support Catheter, 14 X 150cm, US
00856492005647speX LP Shapeable Support Catheter, 14 X 135cm, US
00856492005630speX LP Shapeable Support Catheter, 14 X 90cm, US
10850025525036speX LP Shapeable Support Catheter, 35 X 150cm, US
10850025525029speX LP Shapeable Support Catheter, 35 X 135cm, US
00850025525015speX LP Shapeable Support Catheter, 35 X 90cm, US

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