Duns Number:108179458
Device Description: LeadLoc Depth Stop for St. Jude DBS Leads, non-sterile, 10x
Catalog Number
66-AC-DCS
Brand Name
LeadLoc Depth Stop
Version/Model Number
66-AC-DCS-00520
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
K011992,K011992
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
cc2a46ae-a15c-4812-a66d-6aa21b10b0db
Public Version Date
May 03, 2022
Public Version Number
4
DI Record Publish Date
September 17, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |