Duns Number:966215829
Device Description: Sizing Balloon II
Catalog Number
9-SB-034
Brand Name
Amplatzer™
Version/Model Number
Sizing Balloon II
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
MJN
Product Code Name
Catheter, intravascular occluding, temporary
Public Device Record Key
e77748e2-bba2-4d58-842a-86967ef778c6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 15, 2016
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 63 |
| 3 | A medical device with high risk that requires premarket approval | 82 |