Duns Number:830350380
Device Description: SYRINGE A08A KYPHX XPANDER INFLATION
Catalog Number
-
Brand Name
KYPHON® Inflation Syringe
Version/Model Number
A08A
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"
-
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
K011811
Product Code
DXT
Product Code Name
INJECTOR AND SYRINGE, ANGIOGRAPHIC
Public Device Record Key
3b5f67e9-56ad-425f-8978-e947a9eb9f78
Public Version Date
May 06, 2020
Public Version Number
5
DI Record Publish Date
April 02, 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 | 13352 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
| 3 | A medical device with high risk that requires premarket approval | 190 |
| U | Unclassified | 75 |