Duns Number:830350380
Device Description: KIT NH102PB-CDS 10/2 SPINE ESSEN FF CDS
Catalog Number
-
Brand Name
Balloon Kyphoplasty Essentials Kit
Version/Model Number
NH102PB-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
K041454,K151532
Product Code
HRX
Product Code Name
ARTHROSCOPE
Public Device Record Key
23fad6f4-9ee2-49c0-a03d-77dfa6cc8afe
Public Version Date
February 21, 2019
Public Version Number
4
DI Record Publish Date
February 25, 2017
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 |