Duns Number:317654283
Device Description: EcoBalloonDuo DIL-BI + URO Bilateral double balloon set Ø 11mm for extrap EcoBalloonDuo DIL-BI + URO Bilateral double balloon set Ø 11mm for extraperitoneal surgery,
Catalog Number
1285-50-28S
Brand Name
EcoBalloonDuo DIL-BI + URO
Version/Model Number
1285-50-28S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 15, 2025
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
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
8eec02a4-9227-4391-8b33-d41021d53601
Public Version Date
March 16, 2021
Public Version Number
2
DI Record Publish Date
April 16, 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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 979 |