Duns Number:031284586
Device Description: The NEUROTUBE device Absorbable Woven Polyglycolic Acid Mesh Tube is designed for primary The NEUROTUBE device Absorbable Woven Polyglycolic Acid Mesh Tube is designed for primary or secondary peripheral nerve repair or reconstruction.
Catalog Number
531101240011
Brand Name
Neurotube
Version/Model Number
GEM0240NT
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
K983007
Product Code
JXI
Product Code Name
CUFF, NERVE
Public Device Record Key
dcec7274-2d51-48f2-af50-a139b2b3ed6b
Public Version Date
May 01, 2019
Public Version Number
1
DI Record Publish Date
April 23, 2019
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |