Endo-Ease Discovery Low Profile EED-250

GUDID 00867630000219

Overtube to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and enteroscopy.

SPIRUS MEDICAL LLC

Endoscopic overtube, single-use
Primary Device ID00867630000219
NIH Device Record Key76878075-1972-4960-9053-ed9e7641a4a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo-Ease Discovery Low Profile
Version Model NumberEED-250
Catalog NumberEED-250
Company DUNS969696975
Company NameSPIRUS MEDICAL LLC
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone508-584-1596
Emailejohnson@primomedicalgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100867630000219 [Primary]
GS120867630000206 [Package]
Package: box [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FEDEndoscopic Access Overtube, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by SPIRUS MEDICAL LLC

00867630000202 - Endo-Ease Vista Retrograde2018-07-06 Endo-Ease Endoluminal Advancement System
00867630000219 - Endo-Ease Discovery Low Profile2018-07-06Overtube to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and enteroscopy.
00867630000219 - Endo-Ease Discovery Low Profile2018-07-06 Overtube to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and e
00867630000226 - Endo-Ease Discovery Standard Profile2018-07-06 Overtube to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and e
00867630000233 - Endo-Ease Lubricant2018-07-06 A water soluble and intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic d

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