FDA.reportPublic FDA data

SYNCRO MEDICAL INNOVATIONS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10666073003282547SYNCRO MEDICAL INNOVATIONS, INC.1Y2026-01-01101 Gateway Dr Macon GA US 31210

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860000931304Gabriel Feeding Tube with Balloon - Preassembeled with Stylet+1(888)980-9159sabrygabriel@syncromedical.com
00860000931335Gabriel Feeding Tube with Balloon - and EnFit Connector+1(888)980-9159sabrygabriel@syncomedical.com
00860000931342Gabriel Feeding Tube with Balloon - and EnFit Connector+1(888)980-9159sabrygabriel@syncromedical.com
00860000931359Gabriel Feeding Tube with Balloon - and EnFit Connector+1(888)980-9159sabrygabriel@syncromedical.com
00860000931366Gabriel 3-way EnFit Valve - GEV-0001(888)980-9159sabrygabriel@syncromedical.com
10860000931332Gabriel Feeding Tube with Balloon - and EnFit Connector+1(888)980-9159sabrygabriel@syncomedical.com
10860000931349Gabriel Feeding Tube with Balloon - and EnFit Connector+1(888)980-9159sabrygabriel@syncromedical.com
10860000931356Gabriel Feeding Tube with Balloon - and EnFit Connector+1(888)980-9159sabrygabriel@syncromedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
589151367920696K201741Gabriel 3 Way EnFit ValvePIF2020-11-05
589151192833868K191784Gabriel Feeding Tube with Balloon, and EnFit ConnectorPIF2019-11-15
589151048592429K160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with StyletKNT2016-08-09
589151872145863

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PIF22020-11-05
KNT12016-08-09

PMN#

GUDID#