Duns Number:841842441
Device Description: Expedite and standardize the 'bubble test' for gastrojejunal anastomoses and sleeve gastre Expedite and standardize the 'bubble test' for gastrojejunal anastomoses and sleeve gastrectomy.
Catalog Number
ALT-BA
Brand Name
Bariatric Anastomosis Leak Tester
Version/Model Number
ALT-BA
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
FCY
Product Code Name
Bulb, Inflation, For Endoscope
Public Device Record Key
f4431dd6-664f-49f5-8676-3879ae5cfe48
Public Version Date
October 04, 2019
Public Version Number
1
DI Record Publish Date
September 26, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |