Duns Number:627879687
Device Description: The Ultramatrix EUS balloon -Olympus linear is used for endoscopic ultrasound applications The Ultramatrix EUS balloon -Olympus linear is used for endoscopic ultrasound applications using the balloon method in the gastrointestinal tract.
Catalog Number
USBOL
Brand Name
Ultramatrix
Version/Model Number
USBOL
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
K180731,K180731,K180731
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
b5b0f136-b296-4bc1-9bc3-ce535da87f3a
Public Version Date
March 31, 2020
Public Version Number
4
DI Record Publish Date
August 23, 2018
Package DI Number
10816765014322
Quantity per Package
20
Contains DI Package
00816765014325
Package Discontinue Date
March 31, 2020
Package Status
Not 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 |