FDA.reportPublic FDA data

Spirus Medical, LLC

Matched from indexed company URL: SPIRUS MEDICAL LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30058141623005814162Spirus Medical, LLC1N2026-01-01375 West St W Bridgewater MA US 02379

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
00867630000202Endo-Ease Vista Retrograde - Endo-Ease Endoluminal Advancement System508-584-1596ejohnson@primomedicalgroup.com
00867630000219Endo-Ease Discovery Low Profile - Overtube to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and enteroscopy.508-584-1596ejohnson@primomedicalgroup.com
00867630000226Endo-Ease Discovery Standard Profile - Overtube to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and enteroscopy.508-584-1596ejohnson@primomedicalgroup.com
00867630000233Endo-Ease Lubricant - A water soluble and intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.508-584-1596ejohnson@primomedicalgroup.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
712011402342733K080050SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBEFED2008-05-06
712011090645122K080042SPIRUS MEDICAL SURGICAL INSTRUMENTKMJ2008-04-03
712011011898643K062805MODIFICATION TO ENDO-EASEFED2006-10-13
712011091990118K060235ENDO-EASE ENDOSCOPIC OVERTUBEFDA2006-08-04
712011490018581K052084ENDO-EASE ENDOSCOPIC OVERTUBEFED2005-09-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FED32008-05-06
KMJ12008-04-03
FDA12006-08-04

PMN#

GUDID#