SPEX35

GUDID 00850025525084

Spex Shapeable Support Catheter, 35 X 135cm, US

REFLOW MEDICAL, INC.

Vascular guide-catheter, single-use
Primary Device ID00850025525084
NIH Device Record Key7409eada-efe8-4f69-8fe1-9098ac0f536b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPEX35
Version Model NumberSPN35135US
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

Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com
Phone949-481-0399
Emailquality@reflowmedical.com

Device Dimensions

Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter
Guidewire Diameter0.035 Inch
Catheter Working Length135 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850025525084 [Primary]
GS110850025525081 [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 Date2021-10-01
Device Publish Date2021-09-23

On-Brand Devices [SPEX35]

00856492005135Spex Shapeable Support Catheter, 35X50cm
00856492005128Spex Shapeable Support Catheter, 35X90cm
00856492005111Spex Shapeable Support Catheter, 35X135cm
00856492005104Spex Shapeable Support Catheter, 35X150cm
00850025525091Spex Shapeable Support Catheter, 35 X 150cm, US
00850025525084Spex Shapeable Support Catheter, 35 X 135cm, US
00850025525077Spex Shapeable Support Catheter, 35 X 90cm, US
00850025525060Spex Shapeable Support Catheter, 35 X 50cm, US
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