Catalog Number

66-AC-DCM

Brand Name

LeadLoc Depth Stop

Version/Model Number

66-AC-DCM-00530

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

e8c60628-6db4-49ea-90dc-67ebacffec4d

Public Version Date

May 10, 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

-