Duns Number:530269083
Device Description: the balloon diameter is 15-16.5-18mm,the balloon length is 55mm,the catheter diameter is 7 the balloon diameter is 15-16.5-18mm,the balloon length is 55mm,the catheter diameter is 7 Fr., and the working length is 1800mm,with stainless steel guide wire
Catalog Number
MBD-EM-BA-2
Brand Name
NA
Version/Model Number
MBD-EM-BA-2
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
FGE
Product Code Name
Catheter, Biliary, Diagnostic
Public Device Record Key
6b858a5f-7557-4895-8dcd-f9ba65f3518a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 08, 2016
Package DI Number
26932503523183
Quantity per Package
1
Contains DI Package
16932503523186
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |