Duns Number:830350380
Device Description: KIT KPX153PB-CDS 15/3 FF 1-STEP WITH CDS
Catalog Number
-
Brand Name
KyphPak® First Fracture Tray
Version/Model Number
KPX153PB-CDS
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
K103231
Product Code
HRX
Product Code Name
ARTHROSCOPE
Public Device Record Key
dafe6684-eecd-47e4-8178-5f2f4ba2ecc6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 03, 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 |