Duns Number:480144102
Device Description: NeuroShield® is a chitosan polysaccharide film indicated for the repair of peripheral nerv NeuroShield® is a chitosan polysaccharide film indicated for the repair of peripheral nerve injuries by providing a protective barrierduring tissue healing.
Catalog Number
-
Brand Name
NeuroShield
Version/Model Number
NS4030
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K190246,K190246
Product Code
JXI
Product Code Name
Cuff, Nerve
Public Device Record Key
115afdb5-d519-4b54-a3be-d83b2e907c54
Public Version Date
April 28, 2022
Public Version Number
1
DI Record Publish Date
April 20, 2022
Package DI Number
07640181710201
Quantity per Package
20
Contains DI Package
07640181710010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |