Duns Number:528198569
Device Description: KMC Kyphoplasty System consists of four components:Balloon CatheterTool KitPuncture Needle KMC Kyphoplasty System consists of four components:Balloon CatheterTool KitPuncture NeedleKMC Medical Balloon Catheter Syringe Pump
Catalog Number
FG3006
Brand Name
Puncture Needle
Version/Model Number
FG3006
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
K113742
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
2a56c3cc-3c59-497c-8095-15c69064ebaa
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 26, 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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 106 |