Duns Number:690538160
Device Description: Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine sk
Catalog Number
RN02025E
Brand Name
Nerbridge®
Version/Model Number
RN02025E
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"
-
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
K152967
Product Code
JXI
Product Code Name
Cuff, Nerve
Public Device Record Key
b96328a0-bb46-489e-8f7c-e4a46850a0ad
Public Version Date
May 12, 2022
Public Version Number
6
DI Record Publish Date
April 20, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |