Duns Number:003815548
Device Description: The Dakota Knife® Blade is a stainless steel surgical instrument designed for use in open, The Dakota Knife® Blade is a stainless steel surgical instrument designed for use in open, limited open, and minimally invasive carpal tunnel release surgery. The Dakota Knife® Blade is a single-use, disposable cutting instrument for transecting the transverse carpal ligament
Catalog Number
11-0204-FD2
Brand Name
Dakota Knife Blade®
Version/Model Number
11-0204-FD2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GDZ
Product Code Name
Handle, Scalpel
Public Device Record Key
2137e366-aaab-45bc-944b-81b731c6139c
Public Version Date
January 22, 2021
Public Version Number
4
DI Record Publish Date
September 27, 2016
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 136 |