Duns Number:067140761
Device Description: Tearaway introducer assembly (10 cm sheath)
Catalog Number
23003-045
Brand Name
Nalu Medical, Inc.
Version/Model Number
23003-045
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
-
Product Code
GZB
Product Code Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Public Device Record Key
af68228d-dd15-4c98-beb7-2d46658b3511
Public Version Date
October 03, 2022
Public Version Number
2
DI Record Publish Date
April 21, 2020
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. | 270 |