SPEX14 SPX14090US

GUDID 00856492005357

Spex Shapeable Support Catheter, 14X90cm

REFLOW MEDICAL, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID00856492005357
NIH Device Record Key37b1f0a0-374e-4906-9614-c8b92932da42
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPEX14
Version Model NumberSPX14090US
Catalog NumberSPX14090US
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

Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100856492005357 [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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