Duns Number:317654283
Device Description: EcoBalloon DIL-BI Bilateral dilatation balloon Ø 11mm for extrap EcoBalloon DIL-BI Bilateral dilatation balloon Ø 11mm for extraperitoneal surgery
Catalog Number
1285-50-11
Brand Name
EcoBalloon DIL-BI
Version/Model Number
1285-50-11
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
2b9f7b93-66ab-4b11-ab6d-3d7ff2091296
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 |