Duns Number:083171244
Device Description: NEURAGEN 5MM 3CM GUIDEThe NeuraGen nerve guide is an absorbable implant for the repair of NEURAGEN 5MM 3CM GUIDEThe NeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve discontinuities. NeuraGen nerve guide provides a protective environment for peripheral nerve repair after injury, and is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap. When hydrated, NeuraGen nerve guide is an easy to handle, soft, pliable, nonfriable, porous collagen tube.
Catalog Number
PNG-530
Brand Name
NeuraGen®
Version/Model Number
PNG530
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
cf7d106b-5fe4-49f9-b4cf-29c9b3164924
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 |