FDA.reportPublic FDA data

ESI, INC.

Matched from indexed company URL: ESI CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041815333004181533ESI, INC.1N2026-01-012915 EVEREST LN N Minneapolis MN US 55447
30134907573013490757ESI MANUFACTURING, LLC1N2026-01-01W397 Doering Lane Gleason WI US 54435
30153755533015375553ESI CASES & ACCESSORIES1Y2020-04-254407 East 32nd Street Floor 6 New York NY US 10016

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
B360011B12360Prager Ext Set A1236 - Replacement Part763-473-2533sales@eyesurgin.com
B360011B12630Prager Ext Set B1263 - Replacement Part763-473-2533sales@eyesurgin.com
B360CS2000ClearScan® - ClearScan763-473-2533sales@eyesurgin.com
B360P1000Prager Shell® - Accutome / MicroMedical763-473-2533sales@eyesurgin.com
B360P100AS0Prager Shell® - Accutome Probe, Auto Stop763-473-2533sales@eyesurgin.com
B360P1010Prager Shell® - For DGH 2009 and earlier763-473-2533sales@eyesurgin.com
B360P10120Prager Shell® - For DGH 2010 and later763-473-2533sales@eyesurgin.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
618181605638718K082893PRAGER SHELLITX2008-12-05
618181325921229K080119CLEARSCANITX2008-02-21
618181425671114
2492441547406368
2829761993785528

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ITX42008-12-05

PMN#

Applications#

GUDID#