FDA.reportPublic FDA data

MEDONE SURGICAL, INC.

Matched from indexed company URL: MEDONE LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10643713002865793MEDONE SURGICAL, INC.1Y2026-01-01670 TALLEVAST ROAD SARASOTA FL US 34243
30137576263013757626MEDONE, LLC1Y2020-04-252875 Whiptail Loop East Carlsbad CA US 92011

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
00811313013157MedOne - 3315 MicroDoseTM SF Injection Kit941-359-3129medone@medone.com
00811313013164MedOne - 3316 GentleJect Cannula 25g9413593129medone@medone.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
568331124663856K203264MicroDose InjectorFMF2021-04-26
568331043304178
568331177623519
568331214709863
568331244953355
568331576703250
568331605703224
568331719257233
568331835094512
568331880757293
568331996637130

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMF12021-04-26

PMN#

GUDID#

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