Duns Number:841842441
Device Description: Expedite and standardize the 'bubble test' for colorectal anastomoses. Includes 3 extender Expedite and standardize the 'bubble test' for colorectal anastomoses. Includes 3 extender tips.
Catalog Number
ALT-30EX
Brand Name
Anastomosis Leak Tester-OP EX
Version/Model Number
ALT-30EX
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"
-
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
5271c269-2dba-4dd6-ae76-7d239526e9ea
Public Version Date
December 25, 2019
Public Version Number
1
DI Record Publish Date
December 17, 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 |