Duns Number:627879687
Device Description: The Oracle EUS latex balloon-Olympus radial is used with Olympus radial endoscopes endosco The Oracle EUS latex balloon-Olympus radial is used with Olympus radial endoscopes endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the Upper and lower gastrointestinal tract.
Catalog Number
00711892
Brand Name
Oracle
Version/Model Number
00711892
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)
Yes
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
FDF
Product Code Name
Colonoscope and accessories, flexible/rigid
Public Device Record Key
7c99428b-8d74-4028-a999-d9c8c60a7c30
Public Version Date
November 11, 2020
Public Version Number
2
DI Record Publish Date
April 02, 2020
Package DI Number
10724995184114
Quantity per Package
20
Contains DI Package
00724995184117
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |