Duns Number:007198742
Catalog Number
-
Brand Name
STANDARD BALLOON CATHETER SILICONE
Version/Model Number
890923
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 02, 2018
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
EMX
Product Code Name
BALLOON, EPISTAXIS
Public Device Record Key
4b1c6846-6bd8-4153-a461-fb9af60759df
Public Version Date
October 06, 2022
Public Version Number
3
DI Record Publish Date
September 13, 2018
Package DI Number
00821925022355
Quantity per Package
6
Contains DI Package
00821925040342
Package Discontinue Date
October 02, 2018
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |