Duns Number:627879687
Device Description: The Oracle EUS Balloon is intended to be used in endoscopic procedures that utilize a ball The Oracle EUS Balloon is intended to be used in endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the upper and lower gastrointestinal tract.
Catalog Number
00711891
Brand Name
Oracle
Version/Model Number
00711891
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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"
Yes
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
K111028,K111028
Product Code
FDF
Product Code Name
Colonoscope and accessories, flexible/rigid
Public Device Record Key
98d71bc3-06ac-45d3-9598-be2d7ec130e0
Public Version Date
March 31, 2020
Public Version Number
5
DI Record Publish Date
September 17, 2016
Package DI Number
10816765011932
Quantity per Package
20
Contains DI Package
00816765011935
Package Discontinue Date
March 31, 2020
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |