Duns Number:083171244
Device Description: NeuraGen® nerve guide is an absorbable implant for the repairof peripheral nerve discontin NeuraGen® nerve guide is an absorbable implant for the repairof peripheral nerve discontinuities. NeuraGen® nerve guideprovides a protective environment for peripheral nerve repairafter injury, and is designed to be an interface between the nerveand surrounding tissue and to create a conduit for axonal growthacross a nerve gap. When hydrated, NeuraGen® nerve guideis an easy to handle, soft, pliable, nonfriable, porous collagentube.
Catalog Number
PNG-320
Brand Name
NeuraGen®
Version/Model Number
PNG320
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K011168
Product Code
JXI
Product Code Name
CUFF, NERVE
Public Device Record Key
c9197d42-55af-4c7f-a683-d15a17390aec
Public Version Date
October 25, 2022
Public Version Number
5
DI Record Publish Date
September 22, 2015
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |