SPEX14 SPX14135US

GUDID 00856492005364

Spex Shapeable Support Catheter, 14X135cm

REFLOW MEDICAL, INC.

Vascular guide-catheter, single-use
Primary Device ID00856492005364
NIH Device Record Key9bf58c50-982d-48e2-9a97-747353323010
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPEX14
Version Model NumberSPX14135US
Catalog NumberSPX14135US
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
Phone949.481.0399
Emailquality@reflowmedical.com

Device Dimensions

Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100856492005364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-01-23
Device Publish Date2018-08-06

On-Brand Devices [SPEX14]

00856492005371Spex Shapeable Support Catheter, 14X150cm
00856492005364Spex Shapeable Support Catheter, 14X135cm
00856492005357Spex Shapeable Support Catheter, 14X90cm

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