SPEX35 SPX35135US

GUDID 00856492005111

Spex Shapeable Support Catheter, 35X135cm

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 ID00856492005111
NIH Device Record Key6acc8504-3de1-4f79-b6f7-9885a464e4a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPEX35
Version Model NumberSPX35135US
Catalog NumberSPX35135US
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
GS100856492005111 [Primary]

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-10-30
Device Publish Date2016-09-23

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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