Duns Number:927071162
Device Description: BC3028 Needle Electrodes - Concentric Needle, Non-Wired, 30mm Length, 0.36mm(28G) Diameter BC3028 Needle Electrodes - Concentric Needle, Non-Wired, 30mm Length, 0.36mm(28G) Diameter.
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
BC3028 Needle Electrodes
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
GXZ
Product Code Name
Electrode, Needle
Public Device Record Key
6d407abf-c177-4c72-aa2e-2fccd39844b2
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
August 10, 2016
Package DI Number
20817325020040
Quantity per Package
8
Contains DI Package
10817325020043
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| 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. | 309 |