Duns Number:969696975
Device Description: Overtube to aid endoscopic insertion and advancement to the mid-ileum during diagnostic an Overtube to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and enteroscopy.
Catalog Number
EED-300
Brand Name
Endo-Ease Discovery Standard Profile
Version/Model Number
EED-300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080050,K080050
Product Code
FED
Product Code Name
Endoscopic Access Overtube, Gastroenterology-Urology
Public Device Record Key
360966b3-0a28-4ad7-9403-0c63c654ab95
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
30867630000203
Quantity per Package
4
Contains DI Package
00867630000226
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box