Duns Number:600318101
Device Description: The EndoRings is intended to be attached to the distal end of the endoscope to facilitate The EndoRings is intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: Keeping the suitable depth of endoscope's view field.
Catalog Number
-
Brand Name
EndoRings
Version/Model Number
E102
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FED
Product Code Name
Endoscopic Access Overtube, Gastroenterology-Urology
Public Device Record Key
8668b791-4067-44a4-af0e-b5d9038c72b5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 27, 2016
Package DI Number
17290016767022
Quantity per Package
15
Contains DI Package
07290016767025
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
White carton box