Duns Number:627879687
Device Description: Ultramatrix EUS balloon-Olympus Pentax radial is used for endoscopic ultrasound applicatio Ultramatrix EUS balloon-Olympus Pentax radial is used for endoscopic ultrasound applications using the balloon method in the gastrointestinal tract.
Catalog Number
USBOR
Brand Name
Ultramatrix
Version/Model Number
USBOR
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"
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
-
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
a57ab119-3fef-4a9c-a7c6-3d4f73c75b47
Public Version Date
November 10, 2020
Public Version Number
2
DI Record Publish Date
April 02, 2020
Package DI Number
10724995180772
Quantity per Package
20
Contains DI Package
00724995180775
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 |