Duns Number:083171244
Device Description: NEURAWRAP 3MM NERVE PROTECTORThe NeuraWrap Nerve Protector is an absorbable collagen impla NEURAWRAP 3MM NERVE PROTECTORThe NeuraWrap Nerve Protector is an absorbable collagen implant that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. It is designed to be an interface between the nerve and the surrounding tissue. When hydrated, the NeuraWrap nerve protector is an easy to handle, soft, pliable, nonfriable, porous collagen conduit. The wall of the conduit has a longitudinal slit that allows NeuraWrap nerve protector to be spread open for easy placement over the injured nerve. The resilience of the collagen conduit allows NeuraWrap nerve protector to recover and maintain closure once the device is placed around the nerve.
Catalog Number
NW320
Brand Name
NeuraWrap™
Version/Model Number
NW320
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
K041620
Product Code
JXI
Product Code Name
CUFF, NERVE
Public Device Record Key
a79e533b-60db-4eb1-9ea9-c5cc1b3216da
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 |