SINC

GUDID 00850025525220

REFLOW MEDICAL, INC.

Vascular guide-catheter, single-use
Primary Device ID00850025525220
NIH Device Record Key48540fef-efd2-42ed-8ced-a5f233365eff
Commercial Distribution StatusIn Commercial Distribution
Brand NameSINC
Version Model NumberSINC35135US
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

Device Dimensions

Catheter Working Length135 Centimeter
Catheter Working Length135 Centimeter
Catheter Working Length135 Centimeter
Catheter Working Length135 Centimeter
Catheter Working Length135 Centimeter
Catheter Working Length135 Centimeter
Catheter Working Length135 Centimeter
Catheter Working Length135 Centimeter
Catheter Working Length135 Centimeter
Catheter Working Length135 Centimeter
Catheter Working Length135 Centimeter
Catheter Working Length135 Centimeter
Catheter Working Length135 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850025525220 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-27
Device Publish Date2024-02-19

On-Brand Devices [SINC]

00850025525220SINC35135US
00850025525213The SINC™ (Selective Interventional Navigation Catheter) Support Catheters are single lumen ca

Trademark Results [SINC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SINC
SINC
98193171 not registered Live/Pending
ReFlow Medical, Inc.
2023-09-22
SINC
SINC
98093317 not registered Live/Pending
Granite Creek Capital Partners, L.L.C.
2023-07-20
SINC
SINC
79293967 not registered Live/Pending
Digital Surgery Limited
2020-04-16
SINC
SINC
79211480 5440626 Live/Registered
Nuheara IP Pty Ltd
2017-04-10
SINC
SINC
75132566 2048011 Dead/Cancelled
SEBASTIAN WORLDWIDE INC.
1996-07-11
SINC
SINC
73112371 1076044 Dead/Expired
ZUMCHAK, JOSEPH
1977-01-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.