Duns Number:006966006
Device Description: NH SMOOTH 5.25 WIREFORM CS/50
Catalog Number
-
Brand Name
Sklar
Version/Model Number
96-8968
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HXK
Product Code Name
HOLDER, NEEDLE; ORTHOPEDIC
Public Device Record Key
b4eb1a04-8e54-448e-b06e-05e7ed712765
Public Version Date
January 08, 2021
Public Version Number
4
DI Record Publish Date
March 19, 2019
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 | 13420 |
2 | A medical device with a moderate to high risk that requires special controls. | 881 |