WINGMAN18 WGM18135US

GUDID 00856492005241

Wingman Crossing Catheter, 18X135cm

REFLOW MEDICAL, INC.

Vascular guide-catheter, single-use
Primary Device ID00856492005241
NIH Device Record Keya51dac29-a1ad-4bb9-94ed-4b2993e755ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameWINGMAN18
Version Model NumberWGM18135US
Catalog NumberWGM18135US
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
GS100856492005241 [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 Number6
Public Version Date2019-10-30
Device Publish Date2016-09-23

On-Brand Devices [WINGMAN18]

00856492005258Wingman Crossing Catheter, 18X150cm
00856492005241Wingman Crossing Catheter, 18X135cm
00856492005234Wingman Crossing Catheter, 18X90cm
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.