Duns Number:108179458
Device Description: Lead Adapter CableFor use with O.R. Cable to Guideline System
Catalog Number
MT-LA-03
Brand Name
microTargeting™ Lead Adapter
Version/Model Number
MT-LA-03-00805
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
-
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
K183123
Product Code
GZL
Product Code Name
ELECTRODE, DEPTH
Public Device Record Key
b8926ad4-65f1-4964-8569-73f4756ff161
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
September 01, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |